Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
Key Adverse Events After Childhood Cancer
7 other identifiers
observational
3,885
5 countries
156
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2004
Longer than P75 for all trials
156 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2004
CompletedFirst Submitted
Initial submission to the registry
May 14, 2004
CompletedFirst Posted
Study publicly available on registry
May 19, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMarch 19, 2026
March 1, 2026
9 months
May 14, 2004
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)
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
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
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
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients in active follow-up with key adverse events identified by Children's Oncology Group (COG) institutions
You may qualify if:
- 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:
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (156)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Mattel Children's Hospital UCLA
Los Angeles, California, 90095, United States
Valley Children's Hospital
Madera, California, 93636, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Yale University
New Haven, Connecticut, 06520, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Lee Memorial Health System
Fort Myers, Florida, 33901, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, 32806, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, 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
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Michigan State University Clinical Center
East Lansing, Michigan, 48824-7016, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, 49008, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Columbia Regional
Columbia, Missouri, 65201, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Brooklyn Hospital Center
Brooklyn, New York, 11201, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NYU Winthrop Hospital
Mineola, New York, 11501, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
New York Medical College
Valhalla, New York, 10595, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, 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-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605, United States
Greenville Cancer Treatment Center
Greenville, South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
East Tennessee State University
Johnson City, Tennessee, 37614-0054, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, 79106, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Carilion Clinic Children's Hospital
Roanoke, Virginia, 24014, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Royal Children's Hospital-Brisbane
Herston, Queensland, 4029, Australia
Queensland Children's Hospital
South Brisbane, Queensland, 4101, Australia
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, 5006, Australia
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6008, Australia
Perth Children's Hospital
Perth, Western Australia, 6009, Australia
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Children's Hospital
London, Ontario, N6A 5W9, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
San Jorge Children's Hospital
San Juan, 00912, Puerto Rico
Swiss Pediatric Oncology Group - Geneva
Geneva, 1205, Switzerland
Related Publications (2)
Singh P, Zhou L, Shah DA, Cejas RB, Crossman DK, Jouni M, Magdy T, Wang X, Sharafeldin N, Hageman L, McKenna DE, Horvath S, Armenian SH, Balis FM, Hawkins DS, Keller FG, Hudson MM, Neglia JP, Ritchey AK, Ginsberg JP, Landier W, Burridge PW, Bhatia S. Identification of novel hypermethylated or hypomethylated CpG sites and genes associated with anthracycline-induced cardiomyopathy. Sci Rep. 2023 Aug 4;13(1):12683. doi: 10.1038/s41598-023-39357-2.
PMID: 37542143DERIVEDWang X, Sun CL, Quinones-Lombrana A, Singh P, Landier W, Hageman L, Mather M, Rotter JI, Taylor KD, Chen YD, Armenian SH, Winick N, Ginsberg JP, Neglia JP, Oeffinger KC, Castellino SM, Dreyer ZE, Hudson MM, Robison LL, Blanco JG, Bhatia S. CELF4 Variant and Anthracycline-Related Cardiomyopathy: A Children's Oncology Group Genome-Wide Association Study. J Clin Oncol. 2016 Mar 10;34(8):863-70. doi: 10.1200/JCO.2015.63.4550. Epub 2016 Jan 25.
PMID: 26811534DERIVED
Biospecimen
Peripheral blood and saliva
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Smita Bhatia
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2004
First Posted
May 19, 2004
Study Start
March 25, 2004
Primary Completion
December 31, 2004
Study Completion
March 31, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03