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Key Adverse Events After Childhood Cancer

21 Years
Open (Enrolling)
Cancer Survivor, Cardiovascular Complications, Hematopoietic/Lymphoid Cancer, Unspecified Childhood Solid Tumor, Protocol Specific

Thank you

Trial Information

Key Adverse Events After Childhood Cancer


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

IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in
cases and controls, using constitutional DNA and 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: This is a multicenter study.

DNA from peripheral blood or buccal sample of patients is analyzed for the presence of
polymorphisms in candidate genes associated with an increased risk of late-occurring
complications, such as cardiac dysfunction (closed to accrual as of 4/17/09), myocardial
infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to
accrual as of 11/26/08), and subsequent malignant neoplasms.

Patients also complete a questionnaire detailing family history and health history.

Inclusion Criteria:

- 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 buccal cell specimen) to the
Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital 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
WBC is > 2,000

- Written informed consent from the patient and/or the patient's legally authorized
guardian, obtained in accordance with institutional policies approved by the U.S.
Department of Health and Human Services

- 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

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Smita Bhatia

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Cancer Survivor
  • Cardiovascular Complications
  • Hematopoietic/Lymphoid Cancer
  • Unspecified Childhood Solid Tumor, Protocol Specific



Baylor College of Medicine Houston, Texas  77030
Memorial Sloan Kettering Cancer Center New York, New York  10021
Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Rochester, Minnesota  55905
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Hurley Medical Center Flint, Michigan  48503
Medical City Dallas Hospital Dallas, Texas  75230
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
Bronson Methodist Hospital Kalamazoo, Michigan  49007
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Baptist Hospital of Miami Miami, Florida  33176-2197
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cedars-Sinai Medical Center Los Angeles, California  90048
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Eastern Maine Medical Center Bangor, Maine  04401
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's National Medical Center Washington, District of Columbia  20010-2970
Miami Children's Hospital Miami, Florida  33155-4069
All Children's Hospital St. Petersburg, Florida  33701
Advocate Hope Children's Hospital Oak Lawn, Illinois  60453
Saint Jude Midwest Affiliate Peoria, Illinois  61637
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health Center Portland, Oregon  97227
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Driscoll Children's Hospital Corpus Christi, Texas  78466
Scott and White Memorial Hospital Temple, Texas  76508
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
Southern California Permanente Medical Group Downey, California  90242
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Brooklyn Hospital Center Brooklyn, New York  11201
Children's Hospital Medical Center of Akron Akron, Ohio  44308
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
Winthrop University Hospital Mineola, New York  11501
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
Rady Children's Hospital - San Diego San Diego, California  92123-4282
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Children's Hospital and Research Center at Oakland Oakland, California  94609-1809
City of Hope Medical Center Duarte, California  91010
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania  18017
Lee Memorial Health System Fort Myers, Florida  33902
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Children's Hospital of Alabama Birmingham, Alabama  35233
Connecticut Children's Medical Center Hartford, Connecticut  06106
University of North Carolina Chapel Hill, North Carolina  27599
Duke University Medical Center Durham, North Carolina  27710
University of Florida Gainesville, Florida  32610-0277
Nemours Children's Clinic - Pensacola Pensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan  49503
Yale University New Haven, Connecticut  06520
Legacy Emanuel Children's Hospital Portland, Oregon  97227
BI-LO Charities Children's Cancer Center Greenville, South Carolina  29605
University Of Vermont Burlington,, Vermont  05403
University of Texas Southwestern Medical Center Dallas, Texas  
University of Kentucky Lexington, Kentucky  40536-0098
Tulane University Health Sciences Center New Orleans, Louisiana  70112
Virginia Commonwealth University Richmond, Virginia  
David Geffen School of Medicine at UCLA Los Angeles, California  90095
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
M D Anderson Cancer Center Houston, Texas  77030
Seattle Children's Hospital Seattle, Washington  98105
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Childrens Memorial Hospital Chicago, Illinois  60614
Kaiser Permanente-Oakland Oakland, California  94611
University of Hawaii Honolulu, Hawaii  96813
Saint Luke's Mountain States Tumor Institute Boise, Idaho  83712
Saint Vincent Hospital and Health Services Indianapolis, Indiana  46260
Saint John Hospital and Medical Center Detroit, Michigan  48236
Michigan State University - Breslin Cancer Center East Lansing, Michigan  48824-1313
Kalamazoo Center for Medical Studies Kalamazoo, Michigan  49008
Nevada Cancer Research Foundation CCOP Las Vegas, Nevada  89106
Columbia University Medical Center New York, New York  10032
State University of New York Upstate Medical University Syracuse, New York  13210
Saint Vincent Hospital Green Bay, Wisconsin  54301
University of Illinois Chicago, Illinois  60612
Stony Brook University Medical Center Stony Brook, New York  11794
Cook Children's Medical Center Fort Worth, Texas  76104
West Virginia University Charleston Charleston, West Virginia  25304
The Children's Medical Center of Dayton Dayton, Ohio  45404
Advocate Lutheran General Hospital Park Ridge, Illinois  60068
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida  33136
University of Minnesota Medical Center-Fairview Minneapolis, Minnesota  55455
Children's Oncology Group Arcadia, California  91006-3776
C S Mott Children's Hospital Ann Arbor, Michigan  48109
University Of Missouri-Columbia Columbia, Missouri  65212
Riley Hospital for Children Indianapolis, Indiana  46202
Alfred I duPont Hospital for Children Wilmington, Delaware  19803
Nemours Children's Clinic - Jacksonville Jacksonville, Florida  32207-8426
Nemours Childrens Clinic - Orlando Orlando, Florida  32806
Saint Joseph Children's Hospital of Tampa Tampa, Florida  33607
Children's Healthcare of Atlanta - Egleston Atlanta, Georgia  30322
The Childrens Mercy Hospital Kansas City, Missouri  64108
Rainbow Babies and Childrens Hospital Cleveland, Ohio  44106
Palmetto Health Richland Columbia, South Carolina  29203
East Tennessee Childrens Hospital Knoxville, Tennessee  37916
Saint Joseph's Regional Medical Center Paterson, New Jersey  07503
Texas Tech University Health Science Center-Amarillo Amarillo, Texas  79106
Childrens Hospital-King's Daughters Norfolk, Virginia  23507
Sanford Medical Center-Fargo Fargo, North Dakota  58122
Children's Hospital Colorado Aurora, Colorado  80045
Lucile Packard Children's Hospital Stanford University Palo Alto, California  94304
Greenville Cancer Treatment Center Greenville, South Carolina  29605
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota  57117-5134
Carilion Clinic Children's Hospital Roanoke, Virginia  24014
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington  99204
Mattel Children's Hospital UCLA Los Angeles, California  90095
Georgia Regents University Augusta, Georgia  30912