Study of Kidney Tumors in Younger Patients

September 6, 2023 updated by: Children's Oncology Group

Renal Tumors Classification, Biology, and Banking Study

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies.

(As of Amendment 8, this aim is limited to patients with institutionally classified Stage I to IV focal or diffuse anaplasia identified at initial biopsy or primary nephrectomy OR at delayed nephrectomy/second biopsy.)

II. To maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists.

SECONDARY OBJECTIVES:

I. To monitor outcome for those patients who are not eligible for a subsequent therapeutic study.

II. To describe whether the pulmonary tumor burden correlates with outcome in Stage IV patients.(Completed as of Amendment 7)

III. To describe the sensitivity and specificity of abdominal computed tomography (CT) by comparison with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture and metastases to the liver. (Completed as of Amendment 7)

IV. To compare the sensitivity and specificity of preoperative abdominal CT and MRI for the identification and differentiation of nephrogenic rests and Wilms tumor in children with multiple renal lesions. (Completed as of Amendment 7)

V. To correlate the method of conception (natural versus assisted reproductive technology) with the development of Wilms tumor. (Completed as of Amendment 7)

VI. To evaluate the frequency of integrase interactor 1 (INI1) mutations in renal and extrarenal malignant rhabdoid tumor of the kidney and to determine the incidence of germline and inherited versus somatic mutations to facilitate clinical correlations on the companion study AREN0321. (Completed as of Amendment 7)

OUTLINE:

Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. (LOH and INI1 testing discontinued as of April 2014)

Patients are followed up periodically for 5 years.

Study Type

Observational

Enrollment (Estimated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Hunter Regional Mail Centre, New South Wales, Australia, 2310
        • Recruiting
        • John Hunter Children's Hospital
        • Principal Investigator:
          • Bhavna Padhye
        • Contact:
          • Site Public Contact
          • Phone Number: (02) 4985 5180
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Sydney Children's Hospital
        • Principal Investigator:
          • Bhavna Padhye
        • Contact:
          • Site Public Contact
          • Phone Number: (02) 9382-1721
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • The Children's Hospital at Westmead
        • Contact:
          • Site Public Contact
          • Phone Number: 61-2-9845 1400
        • Principal Investigator:
          • Bhavna Padhye
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Active, not recruiting
        • Royal Brisbane and Women'S Hospital
      • Herston, Queensland, Australia, 4029
        • Active, not recruiting
        • Royal Children's Hospital-Brisbane
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Queensland Children's Hospital
        • Principal Investigator:
          • Steven A. Foresto
        • Contact:
          • Site Public Contact
          • Phone Number: 61 7 3068 1111
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Recruiting
        • Women's and Children's Hospital-Adelaide
        • Contact:
        • Principal Investigator:
          • Maria L. Kirby
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Suspended
        • Monash Medical Center-Clayton Campus
      • Parkville, Victoria, Australia, 3052
        • Suspended
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6008
        • Active, not recruiting
        • Princess Margaret Hospital for Children
      • Perth, Western Australia, Australia, 6009
        • Suspended
        • Perth Children's Hospital
  • Canada
      • Quebec, Canada, G1V 4G2
        • Suspended
        • Centre Hospitalier Universitaire de Quebec
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Contact:
        • Principal Investigator:
          • Douglas R. Strother
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Sarah J. McKillop
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • British Columbia Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 6477 604-875-2345
        • Principal Investigator:
          • David B. Dix
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Suspended
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Recruiting
        • Janeway Child Health Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 866-722-1126
        • Principal Investigator:
          • Lisa A. Goodyear
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Recruiting
        • IWK Health Centre
        • Contact:
        • Principal Investigator:
          • Craig Erker
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Suspended
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Centre
        • Principal Investigator:
          • Mariana P. Silva
        • Contact:
      • London, Ontario, Canada, N6A 5W9
        • Suspended
        • Children's Hospital
      • Ottawa, Ontario, Canada, K1H 8L1
        • Recruiting
        • Children's Hospital of Eastern Ontario
        • Principal Investigator:
          • Donna L. Johnston
        • Contact:
          • Site Public Contact
          • Phone Number: 613-738-3931
      • Toronto, Ontario, Canada, M5G 1X8
        • Suspended
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Suspended
        • Centre Hospitalier Universitaire Sainte-Justine
      • Montreal, Quebec, Canada, H3H 1P3
        • Suspended
        • The Montreal Children's Hospital of the MUHC
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Active, not recruiting
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Suspended
        • Saskatoon Cancer Centre
  • Israel
      • Petah Tikua, Israel, 49202
        • Suspended
        • Schneider Children's Medical Center of Israel
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Suspended
        • Christchurch Hospital
      • Wellington, New Zealand, 6002
        • Completed
        • Wellington Children's Hospital
    • Auckland
      • Grafton, Auckland, New Zealand, 1145
        • Suspended
        • Starship Children's Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00926
        • Recruiting
        • University Pediatric Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 787-474-0333
        • Principal Investigator:
          • Maria E. Echevarria
      • San Juan, Puerto Rico, 00912
        • Suspended
        • San Jorge Children's Hospital
  • Switzerland
      • Bern, Switzerland, 3010
        • Suspended
        • Swiss Pediatric Oncology Group - Bern
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's Hospital of Alabama
        • Contact:
        • Principal Investigator:
          • Matthew A. Kutny
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham Cancer Center
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • USA Health Strada Patient Care Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-388-8721
        • Principal Investigator:
          • Hamayun Imran
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Childrens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 602-546-0920
        • Principal Investigator:
          • Jessica Boklan
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Contact:
        • Principal Investigator:
          • Holly E. Pariury
    • Arkansas
      • Little Rock, Arkansas, United States, 72202-3591
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 501-364-7373
        • Principal Investigator:
          • David L. Becton
      • Little Rock, Arkansas, United States, 72205
        • Active, not recruiting
        • University of Arkansas for Medical Sciences
    • California
      • Downey, California, United States, 90242
        • Recruiting
        • Kaiser Permanente Downey Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 626-564-3455
        • Principal Investigator:
          • Robert M. Cooper
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Anna B. Pawlowska
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 909-558-4050
        • Principal Investigator:
          • Albert Kheradpour
      • Long Beach, California, United States, 90806
        • Recruiting
        • Miller Children's and Women's Hospital Long Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 562-933-5600
        • Principal Investigator:
          • Jacqueline N. Casillas
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Contact:
          • Site Public Contact
          • Phone Number: 323-361-4110
        • Principal Investigator:
          • Leo Mascarenhas
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 310-423-8965
        • Principal Investigator:
          • Fataneh (Fae) Majlessipour
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Mattel Children's Hospital UCLA
        • Contact:
          • Site Public Contact
          • Phone Number: 310-825-6708
        • Principal Investigator:
          • William A. May
      • Madera, California, United States, 93636
        • Recruiting
        • Valley Children's Hospital
        • Contact:
        • Principal Investigator:
          • Karen S. Fernandez
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Laura A. Campbell
      • Oakland, California, United States, 94609-1809
        • Recruiting
        • Children's Hospital and Research Center at Oakland
        • Principal Investigator:
          • Carla B. Golden
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
        • Principal Investigator:
          • Elyssa M. Rubin
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital Stanford University
        • Contact:
        • Principal Investigator:
          • Jay Michael S. Balagtas
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Marcio H. Malogolowkin
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Medical Center Sacramento
        • Principal Investigator:
          • Yung S. Yim
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital - San Diego
        • Contact:
          • Site Public Contact
          • Phone Number: 858-966-5934
        • Principal Investigator:
          • William D. Roberts
      • San Diego, California, United States, 92134
        • Recruiting
        • Naval Medical Center -San Diego
        • Contact:
          • Site Public Contact
          • Phone Number: 619-532-8712
        • Principal Investigator:
          • Yoko T. Udaka
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Medical Center-Mission Bay
        • Contact:
          • Site Public Contact
          • Phone Number: 877-827-3222
        • Principal Investigator:
          • Arun A. Rangaswami
      • San Francisco, California, United States, 94143
        • Active, not recruiting
        • UCSF Medical Center-Parnassus
      • Santa Barbara, California, United States, 93102
        • Recruiting
        • Santa Barbara Cottage Hospital
        • Principal Investigator:
          • David J. Slomiany
        • Contact:
          • Site Public Contact
          • Phone Number: 805-682-7300
      • Torrance, California, United States, 90502
        • Recruiting
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Eduard H. Panosyan
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Timothy P. Garrington
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 303-839-6000
        • Principal Investigator:
          • Jennifer J. Clark
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Connecticut Children's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 860-545-9981
        • Principal Investigator:
          • Michael S. Isakoff
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Nina S. Kadan-Lottick
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Alfred I duPont Hospital for Children
        • Principal Investigator:
          • Ramamoorthy Nagasubramanian
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 202-884-2549
        • Principal Investigator:
          • Jeffrey S. Dome
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 202-444-2223
        • Principal Investigator:
          • Jeffrey A. Toretsky
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • Broward Health Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 954-355-5346
        • Principal Investigator:
          • Hector M. Rodriguez-Cortes
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Golisano Children's Hospital of Southwest Florida
        • Contact:
        • Principal Investigator:
          • Emad K. Salman
      • Fort Myers, Florida, United States, 33901
        • Active, not recruiting
        • Lee Memorial Health System
      • Gainesville, Florida, United States, 32610
        • Suspended
        • University of Florida Health Science Center - Gainesville
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-1847
          • Email: OHR@mhs.net
        • Principal Investigator:
          • Iftikhar Hanif
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Clinic-Jacksonville
        • Contact:
          • Site Public Contact
          • Phone Number: 904-697-3529
        • Principal Investigator:
          • Ramamoorthy Nagasubramanian
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 888-624-2778
        • Principal Investigator:
          • Enrique A. Escalon
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Julio C. Barredo
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 786-596-2000
        • Principal Investigator:
          • Doured Daghistani
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Arnold Palmer Hospital for Children
        • Contact:
        • Principal Investigator:
          • Amy A. Smith
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Nemours Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 407-650-7715
        • Principal Investigator:
          • Ramamoorthy Nagasubramanian
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Fouad M. Hajjar
      • Orlando, Florida, United States, 32806
        • Active, not recruiting
        • Nemours Children's Clinic - Orlando
      • Orlando, Florida, United States, 32806
        • Active, not recruiting
        • UF Cancer Center at Orlando Health
      • Pensacola, Florida, United States, 32504
        • Active, not recruiting
        • Nemours Children's Clinic - Pensacola
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jonathan L. Metts
      • Tampa, Florida, United States, 33607
        • Suspended
        • Saint Joseph's Hospital/Children's Hospital-Tampa
      • Tampa, Florida, United States, 33606
        • Active, not recruiting
        • Tampa General Hospital
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Saint Mary's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 561-881-2815
        • Principal Investigator:
          • Narayana Gowda
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta - Egleston
        • Principal Investigator:
          • Bradley A. George
        • Contact:
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Contact:
        • Principal Investigator:
          • Colleen H. McDonough
      • Macon, Georgia, United States, 31201
        • Recruiting
        • Medical Center of Central Georgia
        • Contact:
        • Principal Investigator:
          • Sushmita Nair
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial Health University Medical Center
        • Principal Investigator:
          • Andrew L. Pendleton
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Contact:
          • Site Public Contact
          • Phone Number: 808-983-6090
        • Principal Investigator:
          • Wade T. Kyono
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96859
        • Active, not recruiting
        • Tripler Army Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Mountain States Tumor Institute
        • Contact:
        • Principal Investigator:
          • Eugenia Chang
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Lurie Children's Hospital-Chicago
        • Principal Investigator:
          • Amy L. Walz
        • Contact:
          • Site Public Contact
          • Phone Number: 773-880-4562
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Mary L. Schmidt
      • Chicago, Illinois, United States, 60637
        • Suspended
        • University of Chicago Comprehensive Cancer Center
      • Maywood, Illinois, United States, 60153
        • Suspended
        • Loyola University Medical Center
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Children's Hospital-Oak Lawn
        • Contact:
          • Site Public Contact
          • Phone Number: 847-723-7570
        • Principal Investigator:
          • Rebecca E. McFall
      • Park Ridge, Illinois, United States, 60068
      • Park Ridge, Illinois, United States, 60068
        • Active, not recruiting
        • Advocate Lutheran General Hospital
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • Saint Jude Midwest Affiliate
        • Contact:
          • Site Public Contact
          • Phone Number: 888-226-4343
        • Principal Investigator:
          • Jaime M. Libes
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
        • Principal Investigator:
          • Gregory P. Brandt
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Suspended
        • Riley Hospital for Children
      • Indianapolis, Indiana, United States, 46260
        • Suspended
        • Saint Vincent Hospital and Health Care Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Blank Children's Hospital
        • Contact:
        • Principal Investigator:
          • Samantha L. Mallory
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • Mariko Sato
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Completed
        • University of Kansas Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Suspended
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Children's Hospital
        • Contact:
        • Principal Investigator:
          • Ashok B. Raj
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Recruiting
        • Children's Hospital New Orleans
        • Contact:
        • Principal Investigator:
          • Lolie C. Yu
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Contact:
        • Principal Investigator:
          • Craig Lotterman
      • New Orleans, Louisiana, United States, 70112
        • Active, not recruiting
        • Tulane University Health Sciences Center
    • Maine
      • Bangor, Maine, United States, 04401
        • Recruiting
        • Eastern Maine Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 207-973-4274
        • Principal Investigator:
          • Nadine P. SantaCruz
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Children's Cancer Program
        • Contact:
        • Principal Investigator:
          • Eric C. Larsen
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Contact:
        • Principal Investigator:
          • Alan D. Friedman
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Contact:
        • Principal Investigator:
          • Jason M. Fixler
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland/Greenebaum Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-888-8823
        • Principal Investigator:
          • Teresa A. York
      • Bethesda, Maryland, United States, 20889-5600
        • Recruiting
        • Walter Reed National Military Medical Center
        • Principal Investigator:
          • Kenneth Lieuw
        • Contact:
          • Site Public Contact
          • Phone Number: 301-319-2100
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-726-5130
        • Principal Investigator:
          • Elizabeth A. Mullen
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 877-442-3324
        • Principal Investigator:
          • Elizabeth A. Mullen
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Floating Hospital for Children at Tufts Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 617-636-5535
        • Principal Investigator:
          • Jason Law
      • Springfield, Massachusetts, United States, 01199
        • Suspended
        • Baystate Medical Center
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Memorial Medical Center - University Campus
        • Contact:
        • Principal Investigator:
          • Stefanie R. Lowas
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • C S Mott Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
        • Principal Investigator:
          • Rajen Mody
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension Saint John Hospital
        • Contact:
        • Principal Investigator:
          • Adonis N. Lorenzana
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Principal Investigator:
          • Alissa M. Martin
        • Contact:
      • East Lansing, Michigan, United States, 48824-7016
        • Recruiting
        • Michigan State University Clinical Center
        • Principal Investigator:
          • Aghiad Chamdin
        • Contact:
          • Site Public Contact
          • Phone Number: 517-975-9547
      • Flint, Michigan, United States, 48503
        • Active, not recruiting
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Suspended
        • Helen DeVos Children's Hospital at Spectrum Health
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Katharina E. Elliott
      • Kalamazoo, Michigan, United States, 49008
        • Active, not recruiting
        • Kalamazoo Center for Medical Studies
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Beaumont Children's Hospital-Royal Oak
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
        • Principal Investigator:
          • Laura K. Gowans
      • Royal Oak, Michigan, United States, 48073
        • Active, not recruiting
        • William Beaumont Hospital-Royal Oak
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Masonic Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 612-624-2620
        • Principal Investigator:
          • Emily G. Greengard
      • Minneapolis, Minnesota, United States, 55404
        • Suspended
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Carola A. Arndt
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Suspended
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65201
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospitals and Clinics
        • Contact:
          • Site Public Contact
          • Phone Number: 816-302-6808
          • Email: rryan@cmh.edu
        • Principal Investigator:
          • Keith J. August
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • David B. Wilson
        • Contact:
      • Saint Louis, Missouri, United States, 63104
        • Recruiting
        • Cardinal Glennon Children's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 314-268-4000
        • Principal Investigator:
          • William S. Ferguson
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
        • Principal Investigator:
          • Robin D. Hanson
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Children's Hospital and Medical Center of Omaha
        • Principal Investigator:
          • Minnie Abromowitch
        • Contact:
          • Site Public Contact
          • Phone Number: 402-955-3949
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Minnie Abromowitch
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Sunrise Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Las Vegas, Nevada, United States, 89135
        • Recruiting
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
      • Las Vegas, Nevada, United States, 89144
        • Suspended
        • Summerlin Hospital Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Julie Kim
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 201-996-2879
        • Principal Investigator:
          • Burton E. Appel
      • Livingston, New Jersey, United States, 07039
        • Active, not recruiting
        • Saint Barnabas Medical Center
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 973-971-5900
        • Principal Investigator:
          • John J. Gregory
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Saint Peter's University Hospital
        • Contact:
        • Principal Investigator:
          • Nibal A. Zaghloul
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-8675
        • Principal Investigator:
          • Richard A. Drachtman
      • Newark, New Jersey, United States, 07112
        • Suspended
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, United States, 07503
        • Recruiting
        • Saint Joseph's Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Alissa Kahn
      • Summit, New Jersey, United States, 07902
        • Active, not recruiting
        • Overlook Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • John F. Kuttesch
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 518-262-5513
        • Principal Investigator:
          • Lauren R. Weintraub
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Principal Investigator:
          • Lisa Gennarini
        • Contact:
      • Brooklyn, New York, United States, 11201
        • Active, not recruiting
        • Brooklyn Hospital Center
      • Buffalo, New York, United States, 14263
        • Suspended
        • Roswell Park Cancer Institute
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Winthrop Hospital
        • Principal Investigator:
          • Mark E. Weinblatt
        • Contact:
      • New Hyde Park, New York, United States, 11040
        • Suspended
        • The Steven and Alexandra Cohen Children's Medical Center of New York
      • New York, New York, United States, 10032
        • Recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Alice Lee
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Pillai Pallavi Madhusoodhan
      • New York, New York, United States, 10065
        • Suspended
        • NYP/Weill Cornell Medical Center
      • New York, New York, United States, 10065
        • Suspended
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • Suspended
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Rochester, New York, United States, 14642
        • Suspended
        • University of Rochester
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Laura E. Hogan
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Philip M. Monteleone
      • Valhalla, New York, United States, 10595
        • Recruiting
        • New York Medical College
        • Contact:
          • Site Public Contact
          • Phone Number: 914-594-3794
        • Principal Investigator:
          • Jessica C. Hochberg
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Stuart H. Gold
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Joel A. Kaplan
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center
        • Principal Investigator:
          • Jessica A. Bell
        • Contact:
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
        • Principal Investigator:
          • Lars M. Wagner
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Andrea R. Whitfield
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • David E. Kram
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Children's Hospital Medical Center of Akron
        • Contact:
          • Site Public Contact
          • Phone Number: 330-543-3193
        • Principal Investigator:
          • Steven J. Kuerbitz
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • James I. Geller
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Rabi Hanna
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Rainbow Babies and Childrens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 216-844-5437
        • Principal Investigator:
          • Duncan S. Stearns
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Principal Investigator:
          • Mark A. Ranalli
        • Contact:
      • Dayton, Ohio, United States, 45404
        • Recruiting
        • Dayton Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-228-4055
        • Principal Investigator:
          • Ayman A. El-Sheikh
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
        • Principal Investigator:
          • Jamie L. Dargart
        • Contact:
          • Site Public Contact
          • Phone Number: 419-824-1842
      • Toledo, Ohio, United States, 43608
        • Suspended
        • Mercy Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Rene Y. McNall-Knapp
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Natalie Warren Bryant Cancer Center at Saint Francis
        • Principal Investigator:
          • Gregory B. Kirkpatrick
        • Contact:
          • Site Public Contact
          • Phone Number: 918-494-2200
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Legacy Emanuel Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2560
        • Principal Investigator:
          • Janice F. Olson
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Katrina Winsnes
      • Portland, Oregon, United States, 97227
        • Active, not recruiting
        • Legacy Emanuel Hospital and Health Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Suspended
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18017
        • Suspended
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Jagadeesh Ramdas
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 717-531-6012
        • Principal Investigator:
          • Lisa M. McGregor
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Frank M. Balis
      • Philadelphia, Pennsylvania, United States, 19134
        • Recruiting
        • Saint Christopher's Hospital for Children
        • Contact:
          • Site Public Contact
          • Phone Number: 215-427-8991
        • Principal Investigator:
          • Gregory E. Halligan
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Principal Investigator:
          • Arthur K. Ritchey
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 401-444-1488
        • Principal Investigator:
          • Jennifer J. Greene Welch
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Jacqueline M. Kraveka
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Prisma Health Richland Hospital
        • Principal Investigator:
          • Stuart L. Cramer
        • Contact:
          • Site Public Contact
          • Phone Number: 803-434-3533
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • BI-LO Charities Children's Cancer Center
        • Contact:
        • Principal Investigator:
          • Nichole L. Bryant
      • Greenville, South Carolina, United States, 29605
        • Active, not recruiting
        • Greenville Cancer Treatment Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Suspended
        • T C Thompson Children's Hospital
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • East Tennessee Childrens Hospital
        • Principal Investigator:
          • Ray C. Pais
        • Contact:
          • Site Public Contact
          • Phone Number: 865-541-8266
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • Saint Jude Children's Research Hospital
        • Principal Investigator:
          • Rachel C. Brennan
        • Contact:
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Principal Investigator:
          • Daniel J. Benedetti
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • The Children's Hospital at TriStar Centennial
        • Principal Investigator:
          • Haydar A. Frangoul
        • Contact:
          • Site Public Contact
          • Phone Number: 615-342-1919
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Texas Tech University Health Sciences Center-Amarillo
        • Contact:
          • Site Public Contact
          • Phone Number: 806-354-5411
        • Principal Investigator:
          • Samer Zaid Kaylani
      • Austin, Texas, United States, 78723
        • Recruiting
        • Dell Children's Medical Center of Central Texas
        • Contact:
        • Principal Investigator:
          • Shannon M. Cohn
      • Corpus Christi, Texas, United States, 78411
        • Recruiting
        • Driscoll Children's Hospital
        • Contact:
        • Principal Investigator:
          • Nkechi I. Mba
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Principal Investigator:
          • Jonathan E. Wickiser
        • Contact:
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Medical City Dallas Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 972-566-5588
        • Principal Investigator:
          • Stanton C. Goldman
      • Fort Sam Houston, Texas, United States, 78234
        • Suspended
        • Brooke Army Medical Center
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Najat C. Daw
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Principal Investigator:
          • Valeria Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
      • Lubbock, Texas, United States, 79410
      • Lubbock, Texas, United States, 79415
        • Recruiting
        • UMC Cancer Center / UMC Health System
        • Principal Investigator:
          • Mohamad M. Al-Rahawan
        • Contact:
          • Site Public Contact
          • Phone Number: 806-775-8590
      • San Antonio, Texas, United States, 78207
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Anne-Marie R. Langevin
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Children's Hospital of South Texas
        • Contact:
        • Principal Investigator:
          • Vinod K. Gidvani-Diaz
      • Temple, Texas, United States, 76508
        • Suspended
        • Scott and White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Suspended
        • Primary Children's Hospital
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Jessica L. Heath
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Cancer Center
        • Principal Investigator:
          • William C. Petersen
        • Contact:
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital
        • Principal Investigator:
          • Marshall A. Schorin
        • Contact:
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of The King's Daughters
        • Contact:
        • Principal Investigator:
          • Eric J. Lowe
      • Portsmouth, Virginia, United States, 23708-2197
        • Active, not recruiting
        • Naval Medical Center - Portsmouth
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Principal Investigator:
          • Madhu S. Gowda
        • Contact:
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Children's
        • Contact:
        • Principal Investigator:
          • Erwood G. Edwards
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 866-987-2000
        • Principal Investigator:
          • Sarah E. Leary
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Judy L. Felgenhauer
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Mary Bridge Children's Hospital and Health Center
        • Contact:
        • Principal Investigator:
          • Robert G. Irwin
      • Tacoma, Washington, United States, 98431
        • Recruiting
        • Madigan Army Medical Center
        • Contact:
        • Principal Investigator:
          • Melissa A. Forouhar
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • West Virginia University Charleston Division
        • Contact:
          • Site Public Contact
          • Phone Number: 304-388-9944
        • Principal Investigator:
          • Mohamad H. Badawi
      • Huntington, West Virginia, United States, 25701
        • Completed
        • Cabell-Huntington Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Contact:
        • Principal Investigator:
          • Catherine A. Long
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Hospital and Clinics
        • Contact:
          • Site Public Contact
          • Phone Number: 800-622-8922
        • Principal Investigator:
          • Kenneth B. De Santes
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Contact:
        • Principal Investigator:
          • Meghen B. Browning

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients newly diagnosed with kidney tumors

Description

Inclusion Criteria:

  • Patients with the first occurrence of any tumor of the kidney identified on CT scan or MRI are eligible for this study; histologic diagnosis is not required prior to enrollment but is required for all patients once on study

  • Eligible tumors include (but are not limited to):

    • Nephroblastic tumors

      • Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse, focal])
      • Nephrogenic rests and nephroblastomatosis
      • Cystic nephroma and cystic partially differentiated nephroblastoma
      • Metanephric tumors (metanephric adenoma, metanephric adenofibroma, metanephric stromal tumor)
    • Mesoblastic nephroma (cellular, classic, mixed)
    • Clear cell sarcoma
    • Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the central nervous system [CNS])
    • Renal epithelioid tumors of childhood (papillary renal cell carcinoma, medullary renal cell carcinoma, renal tumors associated with Xp11.2 translocations, oncocytic renal neoplasms after neuroblastoma)
    • Angiolipoma
    • Ossifying renal tumor of infancy

  • Patients with the first occurrence of the following tumors are also eligible:

    • Extrarenal nephroblastoma or extrarenal neprogenic rests
    • Malignant rhabdoid tumor occurring anywhere outside the central nervous system
  • Required specimens, reports, forms, and copies of imaging studies must be available or will become available for submission and the institution must intend on submitting them as described in the protocol procedures

  • For ALL patients, (with exception of bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy***), the following submissions are required:

    • A complete set of recut hematoxylin and eosin (H & E) slides (including from sampled lymph nodes, if patient had upfront nephrectomy)

      • * Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed favorable histology Wilms tumor [FHWT] patients discovered to have diffuse anaplastic Wilms tumor [DAWT] at delayed nephrectomy and plan to enroll at delayed nephrectomy)

    • Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor, if available.

      • Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed FHWT patients discovered to have DAWT at delayed nephrectomy and plan to enroll at delayed nephrectomy)
    • Institutional pathology report, Specimen Transmittal Form, and Pre-Treatment Pathology Checklist
    • Copies of images and institutional reports of CT and/or MRI abdomen and pelvis, and Pre Treatment Imaging Checklist
    • Copies of images and institutional report of chest CT for all malignant tumors
    • Institutional surgical report(s) and Pre-Treatment Surgical Checklist

    • CRFs: Staging Checklist and Metastatic Disease Form (if metastatic disease is noted on imaging)

      • Patients with bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy via imaging only - these patients will not have central review or have a risk assignment issued, but may contribute to specimen banking for future research. However, if biopsy is done, tissue must be submitted as for other renal tumors, and initial risk assignment will require pathology and surgical rapid central reviews. The Specimen Transmittal Form and Pre Treatment Pathology Checklist are also needed.
    • Please note: if the above required items are not received within 120 days of study enrollment, the patient will be considered off study
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ancillary-correlative (renal tumor classification, biology)
Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. (LOH and INI1 testing discontinued as of April 2014)
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Cytology Specimen Collection Procedure
Correlative studies
Other Names:
  • Cytologic Sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: Up to 5 years from study enrollment
Time from diagnosis to the earliest occurrence of disease progression (if enrolling with measurable disease), first relapse (if enrolling without measurable disease), secondary malignancy, or death. Analysis plans are specific to individual COG-approved projects and biology protocols.
Up to 5 years from study enrollment
Overall survival
Time Frame: Up to 5 years from study enrollment
Time from diagnosis to death. Analysis plans are specific to individual COG-approved projects and biology protocols.
Up to 5 years from study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loss of heterozygosity (LOH testing discontinued as of April 2014)
Time Frame: Baseline
Evaluation of LOH (1p and 16q) status was performed in select patients with newly diagnosed favorable histology Wilms Tumor during the time that AREN0532 and AREN0533 were open to enrollment, in order to direct patients to the appropriate therapeutic protocol and study arm as well as validate the markers' prognostic value.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Elizabeth A Mullen, Children's Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2006

Primary Completion (Estimated)

January 1, 2100

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimated)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AREN03B2 (Other Identifier: CTEP)
  • U10CA180886 (U.S. NIH Grant/Contract)
  • U10CA098543 (U.S. NIH Grant/Contract)
  • UG1CA189958 (U.S. NIH Grant/Contract)
  • NCI-2009-00416 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • COG-AREN03B2
  • CDR0000459797

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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