Clinical Trial COGALTE03N1
Title
Key Adverse Events after Childhood Cancer
Principal Investigator(s)
Details
- Protocol No. COGALTE03N1
- Open Date: 04/20/2005
- Staging: NA
- Age Group: Children
- Scope: National
- Objective: To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of therapeutic protocol. To identify treatment-related and demograpahic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.
- Disease Sites: Miscellaneous; Pediatrics
- Therapies: Correlative
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT00082745
- Secondary Protocol No: ALTE03N1
Description
None Provided.
Eligibility
| Ages Eligible for Study: | N/A and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 (closed to accrual as of 4/17/09):
• 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 (closed to accrual as of 11/26/08):
• 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 (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)
• 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
Learn More
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