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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00082745 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer |
Procedure: cytogenetic analysis Procedure: mutation analysis Procedure: polymorphism analysis Procedure: questionnaire administration |
| Study Type: | Observational |
| Official Title: | Key Adverse Events After Childhood Cancer |
| Estimated Enrollment: | 6900 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
In active follow-up by a Children's Oncology Group (COG) institution
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:
Asymptomatic cardiac dysfunction
Myocardial infarction, meeting 1 of the following criteria (closed to accrual as of 6/5/06):
Ischemic stroke, meeting the following criteria:
Avascular necrosis, meeting the following criteria:
Subsequent malignant neoplasm, meeting the following criteria:
Control group
No clinical evidence of any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 132 Study Locations More Information
| Study ID Numbers: | CDR0000360708, COG-ALTE03N1 |
| Study First Received: | May 14, 2004 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00082745 |
| Health Authority: | Unspecified |
|
unspecified childhood solid tumor, protocol specific long-term effects secondary to cancer therapy in children recurrent/refractory childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage II childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma childhood acute lymphoblastic leukemia in remission childhood acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia de novo myelodysplastic syndromes previously treated childhood rhabdomyosarcoma previously treated myelodysplastic syndromes secondary myelodysplastic syndromes childhood acute myeloid leukemia in remission |
childhood acute myeloid leukemia/other myeloid malignancies recurrent childhood acute myeloid leukemia childhood grade III lymphomatoid granulomatosis recurrent childhood grade III lymphomatoid granulomatosis recurrent childhood large cell lymphoma stage I childhood large cell lymphoma stage II childhood large cell lymphoma stage III childhood large cell lymphoma stage IV childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma Burkitt lymphoma |
|
Juvenile myelomonocytic leukemia Neuroectodermal Tumors, Primitive Histiocytoma, Benign Fibrous Malignant mesenchymal tumor Lymphoma, small cleaved-cell, diffuse Retinoblastoma Small non-cleaved cell lymphoma Osteogenic sarcoma Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Ewing's sarcoma Preleukemia Neoplasm Metastasis Neuroepithelioma Glioma |
Hodgkin Disease Rhabdomyosarcoma Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Astrocytoma Myeloproliferative Disorders Acute myelogenous leukemia Renal cancer Leukemia, Myeloid Neuroectodermal Tumors Brain Neoplasms Histiocytoma Hodgkin lymphoma, childhood Sarcoma |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |
