NCT Number: NCT00003793
Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma
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.
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Notify MeKey information
Conditions
Age range
Up to 17 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Office of S. David Lang, Herston, Brisbane, Queensland, Australia
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
microsatellite instability analysis
Geneticmutation analysis
GeneticPrimary outcomes
-
Event Free Survival
Sponsors and collaborators
Lead sponsor
Children's Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Clinical and Biological Predictors of Therapy-Related Leukemia
Important dates
- Study start
- 1998
- Primary completion
- 2005
- Study completion
- 2007
- First posted
- Jan 27, 2003
- Registry last updated
- Aug 5, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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