Can genes predict late cancer treatment side effects?

NCT ID NCT00082745

Knowledge-focused Sponsor: Children's Oncology Group Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at nearly 4,000 childhood cancer survivors to see if their genes affect their risk of developing serious late complications like heart failure, stroke, bone damage, or a second cancer. Researchers compared survivors who had these problems with those who did not, searching for genetic clues. The goal is to better identify high-risk survivors for closer follow-up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If successful, this could help doctors identify childhood cancer survivors at higher risk for late complications, enabling earlier monitoring or prevention.
What could go wrong: This is an observational study, not a treatment trial. It may not lead to direct changes in care, and genetic links found may not apply to all survivors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,885 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2004

Finished

Mar 2026

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Up to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

childhood malignant neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Childhood malignant neoplasm

Contacts and locations

Locations

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453, United States
Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068, United States
Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States
Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States
Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States
Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States
Ascension Saint John Hospital

Detroit, Michigan, 48236, United States
Augusta University Medical Center

Augusta, Georgia, 30912, United States
BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States
British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada
Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States
Brooklyn Hospital Center

Brooklyn, New York, 11201, United States
C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States
CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada
Carilion Clinic Children's Hospital

Roanoke, Virginia, 24014, United States
Cedars Sinai Medical Center

Los Angeles, California, 90048, United States
Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada
Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322, United States
Children's Hospital

London, Ontario, N6A 5W9, Canada
Children's Hospital Colorado

Aurora, Colorado, 80045, United States
Children's Hospital Los Angeles

Los Angeles, California, 90027, United States
Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States
Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States
Children's Hospital and Research Center at Oakland

Oakland, California, 94609-1809, United States
Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States
Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada
Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States
Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States
Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States
Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States
Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States
Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States
Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
Columbia Regional

Columbia, Missouri, 65201, United States
Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States
Cook Children's Medical Center

Fort Worth, Texas, 76104, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dayton Children's Hospital

Dayton, Ohio, 45404, United States
Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States
East Tennessee State University

Johnson City, Tennessee, 37614-0054, United States
Eastern Maine Medical Center

Bangor, Maine, 04401, United States
Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States
Greenville Cancer Treatment Center

Greenville, South Carolina, 29605, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States
Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada
Hurley Medical Center

Flint, Michigan, 48503, United States
IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada
Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States
Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States
Kaiser Permanente Downey Medical Center

Downey, California, 90242, United States
Kaiser Permanente-Oakland

Oakland, California, 94611, United States
Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, 49008, United States
Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States
Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada
Lee Memorial Health System

Fort Myers, Florida, 33901, United States
Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States
Legacy Emanuel Hospital and Health Center

Portland, Oregon, 97227, United States
Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States
Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States
Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States
Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States
M D Anderson Cancer Center

Houston, Texas, 77030, United States
Maimonides Medical Center

Brooklyn, New York, 11219, United States
Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada
Medical City Dallas Hospital

Dallas, Texas, 75230, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States
Miami Cancer Institute

Miami, Florida, 33176, United States
Michigan State University Clinical Center

East Lansing, Michigan, 48824-7016, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States
NYU Winthrop Hospital

Mineola, New York, 11501, United States
Nationwide Children's Hospital

Columbus, Ohio, 43205, United States
Nemours Children's Clinic - Orlando

Orlando, Florida, 32806, United States
Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States
Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States
Nemours Children's Hospital

Orlando, Florida, 32827, United States
New York Medical College

Valhalla, New York, 10595, United States
Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States
Nicklaus Children's Hospital

Miami, Florida, 33155, United States
Norton Children's Hospital

Louisville, Kentucky, 40202, United States
Perth Children's Hospital

Perth, Western Australia, 6009, Australia
Primary Children's Hospital

Salt Lake City, Utah, 84113, United States
Princess Margaret Hospital for Children

Perth, Western Australia, 6008, Australia
Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States
Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States
Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia
Rady Children's Hospital - San Diego

San Diego, California, 92123, United States
Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States
Riley Hospital for Children

Indianapolis, Indiana, 46202, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia
Royal Children's Hospital

Parkville, Victoria, 3052, Australia
Royal Children's Hospital-Brisbane

Herston, Queensland, 4029, Australia
Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States
Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States
Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States
Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States
Saint Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States
Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States
Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, 46260, United States
San Jorge Children's Hospital

San Juan, 00912, Puerto Rico
Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States
Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States
Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada
Scott and White Memorial Hospital

Temple, Texas, 76508, United States
Seattle Children's Hospital

Seattle, Washington, 98105, United States
St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Stony Brook University Medical Center

Stony Brook, New York, 11794, United States
Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States
Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States
Swiss Pediatric Oncology Group - Geneva

Geneva, 1205, Switzerland
Texas Tech University Health Sciences Center-Amarillo

Amarillo, Texas, 79106, United States
The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3, Canada
Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada
University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610, United States
University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States
University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States
University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States
Valley Children's Hospital

Madera, California, 93636, United States
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States
Women's and Children's Hospital-Adelaide

North Adelaide, South Australia, 5006, Australia
Yale University

New Haven, Connecticut, 06520, United States

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