Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

April 5, 2024 updated by: Children's Oncology Group

Key Adverse Events After Childhood Cancer

This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, avascular necrosis, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger.

II. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol.

III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.

IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls.

V. To explore the role and nature of gene-environment interaction in the development of key adverse events.

OUTLINE:

DNA and RNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.

Study Type

Observational

Enrollment (Estimated)

3885

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
    • 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:
          • Helen Irving
        • 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
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • Royal Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jordan R. Hansford
    • Western Australia
      • Perth, Western Australia, Australia, 6009
      • Perth, Western Australia, Australia, 6008
        • Active, not recruiting
        • Princess Margaret Hospital for Children
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Sarah J. McKillop
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Suspended
        • British Columbia Children's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
        • Principal Investigator:
          • Tanya R. Brown
    • 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
        • Contact:
          • Site Public Contact
          • Phone Number: 905-521-2100
        • Principal Investigator:
          • Uma H. Athale
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Centre
        • Principal Investigator:
          • Mariana P. Silva
        • Contact:
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 519-685-8306
        • Principal Investigator:
          • Shayna M. Zelcer
      • 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
        • Recruiting
        • Hospital For Sick Children
        • Contact:
        • Principal Investigator:
          • Paul C. Nathan
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Recruiting
        • Centre Hospitalier Universitaire Sainte-Justine
        • Principal Investigator:
          • Yvan Samson
        • Contact:
          • Site Public Contact
          • Phone Number: 514-345-4931
      • Montreal, Quebec, Canada, H3H 1P3
        • Active, not recruiting
        • 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
        • Recruiting
        • Saskatoon Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 306-655-2914
        • Principal Investigator:
          • Christopher Mpofu
  • Puerto Rico
      • San Juan, Puerto Rico, 00912
        • Suspended
        • San Jorge Children's Hospital
  • Switzerland
      • Geneva, Switzerland, 1205
        • Suspended
        • Swiss Pediatric Oncology Group - Geneva
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's Hospital of Alabama
        • Principal Investigator:
          • Smita Bhatia
        • Contact:
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham Cancer Center
    • 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
        • Suspended
        • Kaiser Permanente Downey Medical Center
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Saro H. Armenian
      • 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:
          • Vonda L. Crouse
      • 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:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital Stanford University
        • Contact:
        • Principal Investigator:
          • Jay Michael S. Balagtas
      • 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
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Suspended
        • Children's Hospital Colorado
    • 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
    • Florida
      • 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
        • Active, not recruiting
        • University of Florida Health Science Center - Gainesville
      • 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, 33176
        • Recruiting
        • Miami Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 786-596-2000
        • Principal Investigator:
          • Doured Daghistani
      • Miami, Florida, United States, 33136
        • Active, not recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, United States, 33155
        • Suspended
        • Nicklaus Children's Hospital
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Nemours Children's Hospital
        • Principal Investigator:
          • Ramamoorthy Nagasubramanian
        • Contact:
          • Site Public Contact
          • Phone Number: 407-650-7150
      • Orlando, Florida, United States, 32806
        • Active, not recruiting
        • Nemours Children's Clinic - Orlando
      • Pensacola, Florida, United States, 32504
        • Active, not recruiting
        • Nemours Children's Clinic - Pensacola
      • Saint Petersburg, Florida, United States, 33701
        • Suspended
        • Johns Hopkins All Children's Hospital
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Saint Joseph's Hospital/Children's Hospital-Tampa
        • Contact:
        • Principal Investigator:
          • Dana A. Obzut
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta - Egleston
        • Principal Investigator:
          • Lillian R. Meacham
        • Contact:
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Contact:
        • Principal Investigator:
          • Colleen H. McDonough
    • 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
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Mountain States Tumor Institute
        • Contact:
        • Principal Investigator:
          • Eugenia Chang
    • Illinois
      • 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
      • Chicago, Illinois, United States, 60611
        • Suspended
        • Lurie Children's Hospital-Chicago
      • Oak Lawn, Illinois, United States, 60453
        • Suspended
        • Advocate Children's Hospital-Oak Lawn
      • 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
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
          • Site Public Contact
          • Phone Number: 800-248-1199
        • Principal Investigator:
          • Sandeep Batra
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Saint Vincent Hospital and Health Care Center
        • Contact:
        • Principal Investigator:
          • Bassem I. Razzouk
    • Iowa
      • 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
        • Active, not recruiting
        • University of Kansas Cancer Center
    • 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
        • 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, 70112
        • Suspended
        • 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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Dana-Farber Cancer Institute
    • 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:
          • Rama Jasty
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension Saint John Hospital
        • Contact:
        • Principal Investigator:
          • Adonis N. Lorenzana
      • Detroit, Michigan, United States, 48201
        • Active, not recruiting
        • Wayne State University/Karmanos Cancer Institute
      • East Lansing, Michigan, United States, 48824-7016
        • Suspended
        • Michigan State University Clinical Center
      • 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:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49008
        • Active, not recruiting
        • Kalamazoo Center for Medical Studies
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Contact:
          • Site Public Contact
          • Phone Number: 612-813-5193
        • Principal Investigator:
          • Michael K. Richards
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Masonic Cancer Center
        • Principal Investigator:
          • Joseph P. Neglia
        • Contact:
          • Site Public Contact
          • Phone Number: 612-624-2620
      • 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
        • Suspended
        • Columbia Regional
      • 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
        • Contact:
        • Principal Investigator:
          • Robert J. Hayashi
    • 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 Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Michael B. Harris
        • Contact:
          • Site Public Contact
          • Phone Number: 201-996-2879
      • Livingston, New Jersey, United States, 07039
        • Active, not recruiting
        • Saint Barnabas Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Saint Peter's University Hospital
        • Contact:
        • Principal Investigator:
          • Nibal A. Zaghloul
      • 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
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Suspended
        • University of New Mexico Cancer Center
    • New York
      • Brooklyn, New York, United States, 11219
        • Active, not recruiting
        • Maimonides Medical Center
      • Brooklyn, New York, United States, 11201
        • Active, not recruiting
        • Brooklyn Hospital Center
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Denise A. Rokitka
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Winthrop Hospital
        • Principal Investigator:
          • Mark E. Weinblatt
        • Contact:
          • Site Public Contact
          • Phone Number: 516-663-3115
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Danielle N. Friedman
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • New York, New York, United States, 10032
        • Suspended
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • Stony Brook, New York, United States, 11794
        • Suspended
        • Stony Brook University Medical Center
      • 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
        • Suspended
        • New York Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Suspended
        • UNC Lineberger Comprehensive Cancer Center
      • 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
      • 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
        • Suspended
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Rajaram Nagarajan
      • Cleveland, Ohio, United States, 44106
        • Suspended
        • Rainbow Babies and Childrens Hospital
      • 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
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Rene Y. McNall-Knapp
    • 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, 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
      • Philadelphia, Pennsylvania, United States, 19104
        • Suspended
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Principal Investigator:
          • Arthur K. Ritchey
    • South Carolina
      • 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
        • Suspended
        • Sanford USD Medical Center - Sioux Falls
    • Tennessee
      • Johnson City, Tennessee, United States, 37614-0054
        • Active, not recruiting
        • East Tennessee State University
      • Knoxville, Tennessee, United States, 37916
        • Suspended
        • East Tennessee Childrens Hospital
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
        • Principal Investigator:
          • Melissa M. Hudson
        • Contact:
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Debra L. Friedman
    • Texas
      • Amarillo, Texas, United States, 79106
        • Active, not recruiting
        • Texas Tech University Health Sciences Center-Amarillo
      • 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
        • Contact:
        • Principal Investigator:
          • Patrick J. Leavey
      • 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 Worth, Texas, United States, 76104
        • Suspended
        • Cook Children's Medical Center
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Principal Investigator:
          • ZoAnn E. Dreyer
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • M D Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78207
        • Suspended
        • Children's Hospital of San Antonio
      • San Antonio, Texas, United States, 78229
        • Suspended
        • Methodist Children's Hospital of South Texas
      • 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
        • 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
      • Falls Church, Virginia, United States, 22042
        • Suspended
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of The King's Daughters
        • Contact:
        • Principal Investigator:
          • Eric J. Lowe
      • Richmond, Virginia, United States, 23298
        • Suspended
        • Virginia Commonwealth University/Massey Cancer Center
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Clinic Children's Hospital
        • Contact:
        • Principal Investigator:
          • Mandy M. Atkinson
    • Washington
      • Seattle, Washington, United States, 98105
        • Suspended
        • Seattle Children's Hospital
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Judy L. Felgenhauer
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Active, not recruiting
        • West Virginia University Charleston Division
    • 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
      • 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 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in active follow-up with key adverse events identified by Children's Oncology Group (COG) institutions

Description

Inclusion Criteria:

  • ELIGIBILITY CRITERIA - CASES
  • Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • No prior history of allogeneic (non-autologous) hematopoietic cell transplant

  • Development of one of the following key adverse events at any time following initiation of cancer therapy:

    • Cardiac dysfunction; please note: case enrollment has been closed due to achievement of target accrual
    • Ischemic stroke (IS)
    • Subsequent malignant neoplasm (SMN)
    • Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual
  • Submission of a blood specimen (or in certain cases a saliva specimen) to the Coordinating Center at the University of Alabama at Birmingham as per the requirements; please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's white blood cell (WBC) is > 2,000
  • Written informed consent from the patient and/or the patient's legally authorized guardian
  • In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
  • ELIGIBILITY CRITERIA - CONTROLS
  • CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell transplant

  • CONTROLS: No clinical evidence of any of the following key adverse events:

    • Cardiac dysfunction (CD); please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's WBC is > 2,000
    • Ischemic stroke (IS)
    • Avascular necrosis (AVN)
    • Subsequent malignant neoplasm (SMN)
  • CONTROLS: Submission of a blood specimen (or in certain cases a saliva specimen) to the Coordinating Center Laboratory at the University of Alabama at Birmingham as per the requirements
  • CONTROLS: Written informed consent from the patient and/or the patient's legally authorized guardian
  • CONTROLS: In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (genetic analysis)
DNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)
Time Frame: Up to 1 year
Epidemiological, clinical and laboratory variables will be tested for their association with key adverse events. McNemar's test for paired data will be used to compare the unmatched general characteristics of cases and controls.
Up to 1 year
Frequency of mutations or polymorphisms in specific candidate genes in cases and controls
Time Frame: Up to 1 year
Allele frequencies will be estimated by the gene counting method, and the chi-square test will be used to check for departures from Hardy-Weinberg equilibrium.
Up to 1 year
Crude disease-exposure
Time Frame: Up to 1 year
The crude disease-exposure association will be determined by estimating the OR and its 95% confidence interval (CI). This will be done by univariate conditional logistic regression, to account for the matched design. The significance of the OR will be assessed by the Wald test. Backward stepwise regression procedures will be used to develop the final multivariate model and possible interactions will be examined. The fit of the model will be assessed by the logistic regression diagnostics procedure.
Up to 1 year

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: Smita Bhatia, 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)

March 25, 2004

Primary Completion (Actual)

December 31, 2004

Study Registration Dates

First Submitted

May 14, 2004

First Submitted That Met QC Criteria

May 18, 2004

First Posted (Estimated)

May 19, 2004

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTE03N1 (Other Identifier: CTEP)
  • U10CA180886 (U.S. NIH Grant/Contract)
  • U10CA095861 (U.S. NIH Grant/Contract)
  • UG1CA189955 (U.S. NIH Grant/Contract)
  • UG1CA189958 (U.S. NIH Grant/Contract)
  • COG-ALTE03N1 (CTRP (Clinical Trial Reporting Program))
  • CDR0000360708

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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