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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01419509
Enrollment
170
Registered
2011-08-18
Start date
2011-08-31
Completion date
2016-05-31
Last updated
2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

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

Brief summary

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.

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.

Interventions

GENETICDNA methylation analysis
GENETICmicroarray analysis
GENETICpolymerase chain reaction
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Panel of hypermethylation assays for minimal disseminated RMS
Detection of RMS cells in bone marrow

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026