Leukemia Clinical Trial
Official title:
Clinical and Biological Predictors of Therapy-Related Leukemia
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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