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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 14, 2004 |
| Last Updated Date | November 17, 2009 |
| Start Date ICMJE | March 2004 |
| Estimated Primary Completion Date | March 2005 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00082745 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Study of Late-Occurring Complications in Childhood Cancer Survivors |
| Official Title ICMJE | Key Adverse Events After Childhood Cancer |
| Brief Summary | 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. |
| Detailed Description | OBJECTIVES:
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, myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis, 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]) will be accrued for this study. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | Cancer |
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 6900 |
| Completion Date | |
| Estimated Primary Completion Date | March 2005 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | |
| Location Countries ICMJE | United States, Australia, Canada, Puerto Rico, Switzerland |
| Administrative Information | |
| NCT ID ICMJE | NCT00082745 |
| Responsible Party | |
| Study ID Numbers ICMJE | CDR0000360708, COG-ALTE03N1 |
| Study Sponsor ICMJE | Children's Oncology Group |
| Collaborators ICMJE | National Cancer Institute (NCI) |
| Investigators ICMJE | |
| Information Provided By | National Cancer Institute (NCI) |
| Verification Date | November 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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