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Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

Clinical and Biological Predictors of Therapy-Related Leukemia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00003793
Enrollment
294
Registered
2003-01-27
Start date
1998-12-31
Completion date
2007-03-31
Last updated
2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myelodysplastic Syndromes, Sarcoma

Keywords

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

Brief summary

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.

Detailed description

OBJECTIVES: * Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy for sarcoma. * Identify patients who are at increased risk of t-MDS/AML during or after therapy. 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.

Interventions

GENETICmutation analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of sarcoma including: * Rhabdomyosarcoma * Ewing's sarcoma * Primitive neuroectodermal tumor * Fibrosarcoma * Malignant peripheral nerve sheath tumor * Synovial cell sarcoma * Osteosarcoma * Other soft tissue sarcoma * Must be currently receiving intensive or high-dose chemotherapy for sarcoma PATIENT CHARACTERISTICS: Age: * Children Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Design outcomes

Primary

MeasureTime frame
Event Free Survival

Countries

Australia, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026