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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003793 |
Purpose
RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia.
PURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma.
| Condition | Intervention |
|---|---|
|
Leukemia Myelodysplastic Syndromes Sarcoma |
Genetic: clonality analysis Genetic: microsatellite instability analysis Genetic: mutation analysis |
| Study Type: | Observational |
| Official Title: | Clinical and Biological Predictors of Therapy-Related Leukemia |
| Estimated Enrollment: | 321 |
| Study Start Date: | December 1998 |
OBJECTIVES:
OUTLINE: Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy.
Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency (glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles).
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
PROJECTED ACCRUAL: A total of 321 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of sarcoma including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 96 Study Locations| Study Chair: | Stella M. Davies, MBBS, PhD | Children's Hospital Medical Center, Cincinnati |
More Information
| ClinicalTrials.gov Identifier: | NCT00003793 History of Changes |
| Other Study ID Numbers: | CDR0000066936, COG-AB9804, CCG-B9804 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 20, 2010 |
| Health Authority: | United States: Federal Government |
|
secondary acute myeloid leukemia secondary myelodysplastic syndromes localized osteosarcoma metastatic osteosarcoma childhood soft tissue sarcoma nonmetastatic childhood soft tissue sarcoma metastatic childhood soft tissue sarcoma |
childhood fibrosarcoma childhood synovial sarcoma childhood neurofibrosarcoma previously untreated childhood rhabdomyosarcoma localized Ewing sarcoma/peripheral primitive neuroectodermal tumor metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor |
|
Leukemia Myelodysplastic Syndromes Preleukemia Rhabdomyosarcoma Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases |
Precancerous Conditions Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
