Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: November 20, 2010
Last verified: November 2010

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
Myelodysplastic Syndromes
Genetic: clonality analysis
Genetic: microsatellite instability analysis
Genetic: mutation analysis

Study Type: Observational
Official Title: Clinical and Biological Predictors of Therapy-Related Leukemia

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 321
Study Start Date: December 1998
Detailed Description:


  • 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.


Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • Children

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003793

  Show 96 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Study Chair: Stella M. Davies, MBBS, PhD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
No publications provided 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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
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 processed this record on July 20, 2014