Key Adverse Events After Childhood Cancer
N/A
N/A
21 Years
N/A
21 Years
Open (Enrolling)
Both
Cancer Survivor, Cardiovascular Complications, Hematopoietic/Lymphoid Cancer, Unspecified Childhood Solid Tumor, Protocol Specific
Both
Cancer Survivor, Cardiovascular Complications, Hematopoietic/Lymphoid Cancer, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
Key Adverse Events After Childhood Cancer
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 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:
Observational
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:
Yes
Principal Investigator
Smita Bhatia
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Oncology Group
Authority:
United States: Institutional Review Board
Study ID:
ALTE03N1
NCT ID:
NCT00082745
Start Date:
March 2004
Completion Date:
Related Keywords:
- Cancer Survivor
- Cardiovascular Complications
- Hematopoietic/Lymphoid Cancer
- Unspecified Childhood Solid Tumor, Protocol Specific
Name | Location |
|---|---|
| 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 |
