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Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors Clinical research trials and Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors. Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors clinical trial. Participants oftentimes recieve the finest healthcare available for their Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors  Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors
Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors
For Condition: long-term effects secondary to cancer therapy in children,unspecified childhood solid tumor, protocol specific
Status: Not yet recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: A patient's genes may affect the risk of developing complications such as 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: Genetic study to identify cancer survivors who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer.
Details: OBJECTIVES: - Identify key late-occurring complications, specifically, congestive heart failure, myocardial infarction, ischemic stroke, avascular necrosis, 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 congestive heart failure, myocardial infarction, ischemic stroke, and subsequent malignant neoplasms. Patients also complete a questionnaire detailing family history and health history. PROJECTED ACCRUAL: A total of 3,000 patients (750 with late-occurring complications [case group] and 2,250 without late-occurring complications [control group]) will be accrued for this study.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of primary cancer - Received prior therapy on a therapeutic protocol for the treatment of childhood cancer - 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: - Congestive heart failure, meeting the following criteria: - Treatment with anticongestive therapy (e.g., digoxin, diuretics, angiotensin-converting enzyme inhibitors, or beta-blockers) - Confirmed by echocardiogram - Myocardial infarction, meeting 1 of the following criteria: - Definite ECG changes - Typical, atypical, or inadequately described symptoms, probable ECG, and abnormal enzymes, including creatine kinase MB - Typical symptoms, 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: - Congestive heart failure - Myocardial infarction - Ischemic stroke - Avascular necrosis - Subsequent malignant neoplasm PATIENT CHARACTERISTICS: Age - 21 and under at diagnosis 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
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: CDR0000360708; COG-ALTE03N1
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082745
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Health-Related Outcomes in Patients Who Were Previously Treated for Rhabdomyosarcoma
2. Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors
3. Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation
4. Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
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Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors
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