NCT00003793

Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

Clinical and Biological Predictors of Therapy-Related Leukemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 294 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Sarcoma

Interventions

Type	Name	Description
GENETIC	clonality analysis
GENETIC	microsatellite instability analysis
GENETIC	mutation analysis

Timeline

• Start date: 1998-12-01
• Primary completion: 2005-12-01
• Completion: 2007-03-01
• First posted: 2003-01-27
• Last updated: 2014-08-05

Locations

96 sites across 3 countries: United States, Australia, Canada