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DNA Tests in Detecting Disseminated Disease in Tumor, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01419509
First received: August 17, 2011
Last updated: August 20, 2011
Last verified: August 2011
History of Changes
  Purpose

RATIONALE: DNA analysis of tumor, blood, and bone marrow may help doctors predict if the disease has been disseminated.

PURPOSE: This research trial studies DNA tests in detecting disseminated disease in tumor, blood, and bone marrow samples from patients with rhabdomyosarcoma.


Condition Intervention
Sarcoma
 Genetic: DNA methylation analysis
Genetic: microarray analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: DNA Methylation-based Assays for Detecting Disease Spread in Rhabdomyosarcoma

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Panel of hypermethylation assays for minimal disseminated RMS [ Designated as safety issue: No ]
  • Detection of RMS cells in bone marrow [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: August 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To establish a panel of hypermethylation assays for minimal disseminated disease analysis in rhabdomyosarcoma (RMS).
  • To apply the hypermethylation assays to a series of bone marrow specimens from RMS patients.

OUTLINE: Archived tumor, bone marrow, and peripheral blood samples are analyzed for DNA hypermethylation by PCR-based assays and microarray assays. Results are then compared with each patient's clinical and pathological characteristics, and outcomes. Patterns of locus hypermethylation in tumor and paired bone marrow samples are also compared.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with rhabdomyosarcoma (RMS)
  • Tumor, bone marrow, and peripheral blood samples from the Children's Oncology Group D9803 trial of intermediate-risk RMS

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419509

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen R. Master, MD University of Pennsylvania
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01419509     History of Changes
Other Study ID Numbers: CDR0000709088, COG-ARST11B1
Study First Received: August 17, 2011
Last Updated: August 20, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
alveolar childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
mixed childhood rhabdomyosarcoma
 pleomorphic childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
nonmetastatic childhood soft tissue sarcoma

Additional relevant MeSH terms:
Rhabdomyosarcoma
Sarcoma
Myosarcoma
Neoplasms, Muscle Tissue
 Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013