View Clinical Trial (Medical Research Study)
Key Adverse Events After Childhood Cancer
| City: |
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Hackensack |
| State: |
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New Jersey |
| Zip Code: |
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07601 |
| Conditions: |
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Cancer |
| Purpose: |
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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.
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| Study Summary: |
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OBJECTIVES:
- Identify key late-occurring complications, specifically, 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 neoplasm, in childhood cancer survivors.
- Correlate key late-occurring complications with pathology and staging of the primary
malignancy and therapeutic treatment protocol details in these patients.
- Identify treatment-related and demographic risk factors by comparing patients who
develop late-occurring complications (case group) vs those with the same primary
malignancy who do not develop late-occurring complications (control group).
- Compare the frequency of mutations or polymorphisms in specific candidate genes in both
the case and control groups using constitutional DNA and RNA from both groups.
- Explore the role and nature of gene-environment interaction in the development of
late-occurring complications in these patients.
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.
PROJECTED ACCRUAL: A total of 6,900 patients (1,725 with late-occurring complications [case
group] and 5,175 without late-occurring complications [control group] [myocardial infarction
patients closed to accrual as of 6/5/06, avascular necrosis patients closed to accrual as of
11/26/08, cardiac dysfunction patients closed to accrual as of 4/17/09]) will be accrued for
this study.
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| Criteria: |
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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
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| NCT ID: |
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NCT00082745 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Hackensack, New Jersey 07601
United States
Clinical Trials Office - Hackensack University Medical Center
Phone: 201-996-2879
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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