Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

April 12, 2024 updated by: Children's Oncology Group

Neuroblastoma Biology Studies

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To prospectively analyze the factors that are currently used for risk-group assignment (v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog [MYCN] copy number by fluorescent in situ hybridization [FISH], deoxyribonucleic acid [DNA] content by flow cytometry, and tumor histology using the International Neuroblastoma Pathologic Classification System) in neuroblastoma tumors at the time of diagnosis.

II. To maintain a reference bank containing clinically and genetically characterized frozen tumor tissue, tumor DNA and ribonucleic acid (RNA), histology slides and paraffin blocks, neuroblastoma-derived cell lines, patient serum and paired normal DNA obtained at the time of diagnosis, at the time of second-look surgery and at the time of relapse for future research studies.

III. To prospectively analyze 1p, 11q, 14q and 17q allelic status, MYCN copy number by quantitative polymerase chain reaction (PCR); and the expression pattern of neurotrophin-related genes in diagnostic neuroblastoma tumors, and assay for the presence of rare tumor cells in biological specimens by reverse transcription (RT)-PCR; these biological variables will be analyzed for independent clinical significance compared to MYCN amplification, International Neuroblastoma Staging System (INSS) stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.

IV. To build a database of the known biologic prognostic factors for patients on therapeutic studies.

V. To serve as a Registry for neuroblastoma patients whose tumors demonstrate clinical and genetic features defined as ?Low Risk? for treatment failure in the absence of adjuvant therapy.

SECONDARY OBJECTIVES:

I. To prospectively analyze the concordance between detection of MYCN amplification in tumor samples and quantitative detection of MYCN DNA in serum, and to analyze the prognostic significance of MYCN amplification as detected in serum samples.

II. To build a database that includes information regarding the presentation and natural history of neuroblastoma-associated health problems including but not limited to opsoclonus myoclonus ataxia (OMA) and/or spinal cord compression.

OUTLINE:

Patients undergo collection of blood, tissue, and bone marrow samples for analysis via RT-PCR, quantitative PCR, flow cytometry, and FISH.

After completion of study, patients are followed up periodically.

Study Type

Observational

Enrollment (Estimated)

10000

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
      • Randwick, New South Wales, Australia, 2031
      • Westmead, New South Wales, Australia, 2145
    • 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
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
    • Victoria
      • Parkville, Victoria, Australia, 3052
    • Western Australia
      • Perth, Western Australia, Australia, 6009
      • Perth, Western Australia, Australia, 6008
        • Active, not recruiting
        • Princess Margaret Hospital for Children
  • Canada
      • Quebec, Canada, G1V 4G2
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Sarah J. McKillop
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
        • Principal Investigator:
          • Tanya R. Brown
    • 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:
          • Site Public Contact
          • Phone Number: 902-470-6767
        • Principal Investigator:
          • Conrad V. Fernandez
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • McMaster Children's Hospital at Hamilton Health Sciences
        • Principal Investigator:
          • Carol A. Portwine
        • Contact:
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Centre
        • Principal Investigator:
          • Mariana P. Silva
        • Contact:
      • London, Ontario, Canada, N6A 5W9
      • Ottawa, Ontario, Canada, K1H 8L1
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Hospital For Sick Children
        • Principal Investigator:
          • Meredith S. Irwin
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
      • Montreal, Quebec, Canada, H3T 1C5
        • Recruiting
        • Centre Hospitalier Universitaire Sainte-Justine
        • Principal Investigator:
          • Yvan Samson
        • Contact:
          • Site Public Contact
          • Phone Number: 514-345-4931
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Active, not recruiting
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Recruiting
        • Saskatoon Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 306-655-2914
        • Principal Investigator:
          • Christopher Mpofu
  • Netherlands
      • Groningen, Netherlands, 9700 GZ
        • Recruiting
        • University Medical Center Groningen
        • Principal Investigator:
          • Michael D. Hogarty
        • Contact:
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Recruiting
        • Christchurch Hospital
        • Principal Investigator:
          • Robin P. Corbett
        • Contact:
          • Site Public Contact
          • Phone Number: 03 364 0640
    • Auckland
      • Grafton, Auckland, New Zealand, 1145
  • Puerto Rico
      • Caguas, Puerto Rico, 00726
        • Recruiting
        • HIMA San Pablo Oncologic Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 787-653-3434
        • Principal Investigator:
          • Jhon A. Guerra
      • San Juan, Puerto Rico, 00926
        • Recruiting
        • University Pediatric Hospital
        • Principal Investigator:
          • Luis A. Clavell
        • Contact:
          • Site Public Contact
          • Phone Number: 787-474-0333
      • San Juan, Puerto Rico, 00912
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • Suspended
        • King Faisal Specialist Hospital and Research Centre
  • Switzerland
      • Bern, Switzerland, 3010
        • Suspended
        • Swiss Pediatric Oncology Group - Bern
      • Geneva, Switzerland, 1205
        • Suspended
        • Swiss Pediatric Oncology Group - Geneva
      • Lausanne, Switzerland, 1011
        • Active, not recruiting
        • Swiss Pediatric Oncology Group - Lausanne
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
      • 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
        • Principal Investigator:
          • Felicia L. Wilson
        • Contact:
          • Site Public Contact
          • Phone Number: 800-388-8721
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Mesa, Arizona, United States, 85202
      • 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, 85724
        • Recruiting
        • The University of Arizona Medical Center-University Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 520-626-9008
        • Principal Investigator:
          • Yi Zeng
    • Arkansas
      • Little Rock, Arkansas, United States, 72202-3591
      • 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: 510-891-3400
        • 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
        • Principal Investigator:
          • Albert Kheradpour
        • Contact:
          • Site Public Contact
          • Phone Number: 909-558-3375
      • Long Beach, California, United States, 90806
        • Recruiting
        • Miller Children's and Women's Hospital Long Beach
        • Principal Investigator:
          • Pamela H. Kempert
        • Contact:
      • Los Angeles, California, United States, 90027
      • 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
      • Madera, California, United States, 93636
      • 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
        • Contact:
        • Principal Investigator:
          • Carla B. Golden
      • Orange, California, United States, 92868
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital Stanford University
        • Principal Investigator:
          • Sheri L. Spunt
        • Contact:
      • 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
        • Contact:
        • Principal Investigator:
          • Yung S. Yim
      • San Diego, California, United States, 92123
      • 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
        • Principal Investigator:
          • Katherine K. Matthay
        • Contact:
          • Site Public Contact
          • Phone Number: 877-827-3222
      • 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
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 310-222-3621
        • Principal Investigator:
          • Eduard H. Panosyan
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
        • Principal Investigator:
          • Jennifer J. Clark
        • Contact:
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Presbyterian - Saint Lukes Medical Center - Health One
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
    • Connecticut
      • Hartford, Connecticut, United States, 06106
      • 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
      • 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
      • Fort Myers, Florida, United States, 33901
        • Active, not recruiting
        • Lee Memorial Health System
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Health Science Center - Gainesville
        • Contact:
        • Principal Investigator:
          • William B. Slayton
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Principal Investigator:
          • Iftikhar Hanif
        • Contact:
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Clinic-Jacksonville
        • Contact:
        • Principal Investigator:
          • Ramamoorthy Nagasubramanian
      • Miami, Florida, United States, 33155
      • 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:
        • Principal Investigator:
          • Doured Daghistani
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Arnold Palmer Hospital for Children
        • Principal Investigator:
          • Don E. Eslin
        • Contact:
      • Orlando, Florida, United States, 32827
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Florida Hospital 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
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Contact:
        • Principal Investigator:
          • Juan F. Rico
      • Tampa, Florida, United States, 33607
        • Suspended
        • Saint Joseph's Hospital/Children's Hospital-Tampa
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Contact:
        • Principal Investigator:
          • Colleen H. McDonough
      • 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
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Susan L. Cohn
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Mary L. Schmidt
      • Maywood, Illinois, United States, 60153
        • Suspended
        • Loyola University Medical Center
      • Oak Lawn, Illinois, United States, 60453
      • 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
        • Recruiting
        • Riley Hospital for Children
        • Principal Investigator:
          • Kamnesh R. Pradhan
        • Contact:
          • Site Public Contact
          • Phone Number: 800-248-1199
      • Indianapolis, Indiana, United States, 46260
        • Suspended
        • Saint Vincent Hospital and Health Care Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
      • 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
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Principal Investigator:
          • Vlad C. Radulescu
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
      • 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
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Principal Investigator:
          • Allen R. Chen
        • Contact:
      • 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:
          • Alison M. Friedmann
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 877-442-3324
        • Principal Investigator:
          • Suzanne Shusterman
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Floating Hospital For Children at Tufts Medical Center
        • Principal Investigator:
          • Michael J. Kelly
        • Contact:
          • Site Public Contact
          • Phone Number: 617-636-5535
      • Springfield, Massachusetts, United States, 01199
        • Recruiting
        • Baystate Medical Center
        • Contact:
        • Principal Investigator:
          • Joanna G. Luty
      • Worcester, Massachusetts, United States, 01655
        • Suspended
        • University of Massachusetts Medical School
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • 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:
          • Roland L. Chu
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
      • East Lansing, Michigan, United States, 48824-7016
        • Recruiting
        • Michigan State University Clinical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 517-975-9547
        • Principal Investigator:
          • Renuka Gera
      • Flint, Michigan, United States, 48503
        • Active, not recruiting
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital at Spectrum Health
        • Contact:
        • Principal Investigator:
          • Jessica M. Foley
      • 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: 248-551-0360
        • Principal Investigator:
          • Laura K. Gowans
      • Royal Oak, Michigan, United States, 48073
        • Active, not recruiting
        • William Beaumont Hospital-Royal Oak
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Principal Investigator:
          • Michael K. Richards
        • Contact:
      • Minneapolis, Minnesota, United States, 55455
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Carola A. Arndt
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • Gail C. Megason
        • Contact:
          • Site Public Contact
          • Phone Number: 601-815-6700
    • Missouri
      • Columbia, Missouri, United States, 65201
      • Kansas City, Missouri, United States, 64108
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • David B. Wilson
        • Contact:
      • Saint Louis, Missouri, United States, 63104
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Bethany G. Sleckman
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Children's Hospital and Medical Center of Omaha
        • Principal Investigator:
          • Minnie Abromowitch
        • Contact:
      • 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
        • Recruiting
        • Summerlin Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Alan K. Ikeda
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Suspended
        • Dartmouth Hitchcock Medical Center
    • 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
        • Suspended
        • Saint Barnabas Medical Center
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Principal Investigator:
          • Steven L. Halpern
        • Contact:
          • Site Public Contact
          • Phone Number: 973-971-5900
      • New Brunswick, New Jersey, United States, 08901
      • 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
        • Recruiting
        • Newark Beth Israel Medical Center
        • Principal Investigator:
          • Teena Bhatla
        • Contact:
          • Site Public Contact
          • Phone Number: 973-926-7230
      • Paterson, New Jersey, United States, 07503
        • Suspended
        • Saint Joseph's Regional Medical Center
      • 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, 11219
        • Recruiting
        • Maimonides Medical Center
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
      • Brooklyn, New York, United States, 11201
        • Active, not recruiting
        • Brooklyn Hospital Center
      • Brooklyn, New York, United States, 11203
        • Recruiting
        • State University of New York Downstate Medical Center
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Clare J. Twist
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Winthrop Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 866-946-8476
        • Principal Investigator:
          • Mark E. Weinblatt
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • The Steven and Alexandra Cohen Children's Medical Center of New York
        • Contact:
        • Principal Investigator:
          • Arlene S. Redner
      • 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, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Stephen S. Roberts
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Principal Investigator:
          • Sharon L. Gardner
        • Contact:
      • 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
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Angela R. Girvin
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Principal Investigator:
          • Robert I. Parker
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
      • 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
        • Recruiting
        • Mission Hospital Inc-Memorial Campus
        • Contact:
        • Principal Investigator:
          • Douglas J. Scothorn
      • 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
        • Principal Investigator:
          • Susan G. Kreissman
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
      • 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:
          • Thomas W. McLean
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45229
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Rainbow Babies and Childrens Hospital
        • Principal Investigator:
          • John J. Letterio
        • Contact:
          • Site Public Contact
          • Phone Number: 216-844-5437
      • Cleveland, Ohio, United States, 44195
        • Suspended
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43205
      • Dayton, Ohio, United States, 45404
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • The Toledo Hospital/Toledo 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
      • Youngstown, Ohio, United States, 44501
        • Recruiting
        • Tod Children's Hospital - Forum Health
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
    • 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
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Linda C. Stork
      • Portland, Oregon, United States, 97227
        • Active, not recruiting
        • Legacy Emanuel Hospital and Health Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Principal Investigator:
          • Felipe S. Bautista-Otanez
        • Contact:
      • Bethlehem, Pennsylvania, United States, 18017
        • Active, not recruiting
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Jagadeesh Ramdas
      • Hershey, Pennsylvania, United States, 17033
        • Suspended
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19134
      • Pittsburgh, Pennsylvania, United States, 15224
    • 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
      • 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
      • Johnson City, Tennessee, United States, 37614-0054
        • Recruiting
        • East Tennessee State University
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
      • 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
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Devang J. Pastakia
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Amarillo, Texas, United States, 79106
        • Active, not recruiting
        • Texas Tech University Health Sciences Center-Amarillo
      • Austin, Texas, United States, 78723
      • Corpus Christi, Texas, United States, 78411
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Principal Investigator:
          • Tanya C. Watt
        • 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
      • El Paso, Texas, United States, 79905
      • Fort Sam Houston, Texas, United States, 78234
        • Suspended
        • Brooke Army Medical Center
      • Fort Worth, Texas, United States, 76104
      • Galveston, Texas, United States, 77555-0565
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Douglas J. Harrison
        • Contact:
          • Site Public Contact
          • Phone Number: 877-312-3961
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
        • Principal Investigator:
          • Jennifer H. Foster
      • Lubbock, Texas, United States, 79410
      • 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
        • Recruiting
        • Scott and White Memorial Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 254-724-5407
        • Principal Investigator:
          • Nicholas W. McGregor
    • Utah
      • Salt Lake City, Utah, United States, 84113
    • 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
      • 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
        • Contact:
        • Principal Investigator:
          • Gita V. Massey
      • Roanoke, Virginia, United States, 24014
    • Washington
      • Seattle, Washington, United States, 98105
      • Seattle, Washington, United States, 98112
        • Recruiting
        • Kaiser Permanente Washington
        • Contact:
        • Principal Investigator:
          • Michael D. Hogarty
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Principal Investigator:
          • Judy L. Felgenhauer
        • Contact:
      • Tacoma, Washington, United States, 98405
      • 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:
          • Ashley E. Meyer
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • Stephan R. Paul
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Catherine A. Long
        • Contact:
      • 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:
          • Paul D. Harker-Murray

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 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Description

Inclusion Criteria:

  • All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study

    • There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype

  • Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:

    • Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
  • It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy

  • Exceptions

    • In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:

      • For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted

      • For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment

        • Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
      • Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
  • 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

Exclusion Criteria:

  • Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol

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?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ancillary-Correlative (cytology specimen collection)
Patients undergo collection of blood, tissue, and bone marrow samples for analysis via RT-PCR, quantitative PCR, flow cytometry, and FISH.
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
Factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology)
Time Frame: Up to 3 years
Life tables, Kaplan-Meier survival curves, log-rank tests, and Cox regression will be used to explore the relationship of laboratory variables to outcome.
Up to 3 years
Prevalence of 1p, 11q, 14q, and 17q allelic status
Time Frame: Up to 3 years
These biological variables will be analyzed for independent clinical significance compared to MYCN amplification, INSS stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.
Up to 3 years
MYCN copy number by quantitative PCR
Time Frame: Up to 3 years
These biological variables will be analyzed for independent clinical significance compared to MYCN amplification, INSS stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.
Up to 3 years
Expression pattern of neurotrophin-related genes in diagnostic neuroblastoma tumors
Time Frame: Up to 3 years
These biological variables will be analyzed for independent clinical significance compared to MYCN amplification, INSS stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.
Up to 3 years
Presence of rare tumor cells in biological specimens by RT-PCR
Time Frame: Up to 3 years
These biological variables will be analyzed for independent clinical significance compared to MYCN amplification, INSS stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.
Up to 3 years
Database of the known biologic prognostic factors for patients on therapeutic studies
Time Frame: Up to 3 years
During the testing for treatment effect in Phase III trials, the biologic prognostic factors may be needed for adjustment in the Cox regression model-building process.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MYCN status per tumor
Time Frame: Up to 3 years
Cross tabulations of MYCN status per tumor versus MYCN status per blood will be generated, the percentage concordant and the percentage discordant will be calculated, and receiver operating characteristic (ROC) analyses will be performed. Kaplan-Meier curves of MYCN status per blood will be generated, and a logrank test comparison performed. The prognostic ability of MYCN status per tumor versus MYCN status per blood will be tested in a multivariable Cox model.
Up to 3 years
MYCN status per blood
Time Frame: Up to 3 years
Cross tabulations of MYCN status per tumor versus MYCN status per blood will be generated, the percentage concordant and the percentage discordant will be calculated, and ROC analyses will be performed. Kaplan-Meier curves of MYCN status per blood will be generated, and a logrank test comparison performed. The prognostic ability of MYCN status per tumor versus MYCN status per blood will be tested in a multivariable Cox model.
Up to 3 years
Incidence of OMA
Time Frame: Up to 3 years
Descriptive analysis will be performed.
Up to 3 years
Incidence of spinal cord compression
Time Frame: Up to 3 years
Descriptive analysis will be performed.
Up to 3 years
Presentation with multifocal primary tumors
Time Frame: Up to 3 years
Descriptive analysis will be performed.
Up to 3 years

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: Michael Hogarty, Children's Oncology Group

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)

November 6, 2000

Primary Completion (Estimated)

January 1, 2100

Study Registration Dates

First Submitted

May 16, 2009

First Submitted That Met QC Criteria

May 16, 2009

First Posted (Estimated)

May 19, 2009

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANBL00B1 (Other Identifier: CTEP)
  • U10CA180886 (U.S. NIH Grant/Contract)
  • U10CA098543 (U.S. NIH Grant/Contract)
  • UG1CA189958 (U.S. NIH Grant/Contract)
  • NCI-2009-00397 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000078642

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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