Study of Late-Occurring Complications in Childhood Cancer Survivors

Status: Recruiting
Phase: N/A
Diagnosis: Pediatric Brain Tumor, Pediatric Solid Tumors
NCT ID: NCT00082745 (View complete trial on
DFCI Protocol ID: 05-121


This clinical trial is studying 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, heart attack, 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.


Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Peter Manley, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,

Eligibility Criteria

DISEASE CHARACTERISTICS: - Diagnosis of primary cancer at age 21 or younger - In active follow-up by a Children's Oncology Group (COG) institution - Date of last visit or contact by a COG institution within the past 24 months - Case group - Development of one of the following key adverse events after initiation of prior cancer therapy: - Cardiac dysfunction, meeting 1 of the following criteria: - Symptomatic cardiac dysfunction, including current or previous diagnosis of congestive heart failure based on any of the following clinical criteria: - Pulmonary and/or peripheral edema - Dyspnea - Orthopnea - Fatigue - Hepatomegaly - Asymptomatic cardiac dysfunction - Ejection fraction < 40% on echocardiogram OR MUGA and/or fractional shortening < 28% on echocardiogram without clinical symptoms - Myocardial infarction, meeting 1 of the following criteria (closed to accrual as of 6/5/06): - Definite ECG changes - Typical, atypical, or inadequately described symptoms AND probable ECG, AND abnormal enzymes, including creatine kinase MB - Typical symptoms AND abnormal enzymes, including creatine kinase MB, AND ischemic ECG, non-codable ECG, or ECG not available - Ischemic stroke, meeting the following criteria: - Fixed neurological deficit lasting more than 24 hours - Confirmed by CT scan or MRI within 7 days of onset of symptoms - No subarachnoid or intracerebral hemorrhage, transient ischemic attacks, or amaurosis fugax - Avascular necrosis, meeting the following criteria: - Clinical symptoms of joint pain, joint stiffness, or decreased range of motion - Confirmed by plain radiographs, CT scan, MRI, or bone scan - Subsequent malignant neoplasm, meeting the following criteria: - Histologically distinct neoplasm developing in patients treated for a primary cancer - Confirmed by an institutional pathology report - Control group - No clinical evidence of any of the following: - Cardiac dysfunction - Myocardial infarction (closed to accrual as of 6/5/06) - Ischemic stroke - Avascular necrosis - Subsequent malignant neoplasm PATIENT CHARACTERISTICS: Age - 21 and under at diagnosis, any age at study entry Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - See Disease Characteristics PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No prior allogeneic (non-autologous) hematopoietic cell transplant
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