- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01419509
DNA Tests in Detecting Disseminated Disease in Tumor, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma
DNA Methylation-based Assays for Detecting Disease Spread in Rhabdomyosarcoma
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Panel of hypermethylation assays for minimal disseminated RMS
|
Detection of RMS cells in bone marrow
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen R. Master, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARST11B1 (Other Identifier: Children's Oncology Group)
- COG-ARST11B1 (Other Identifier: Children's Oncology Group)
- NCI-2011-02985 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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