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 ClinicalTrials.gov)
DFCI Protocol ID: 05-121
RATIONALE: 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. PURPOSE: 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.
Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston
Overall PI:
Peter Manley, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
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