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NCT01419509 Clinical Trial

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

Sarcoma Clinical Trial

Official title:
DNA Methylation-based Assays for Detecting Disease Spread in Rhabdomyosarcoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01419509
Other study ID # ARST11B1
Secondary ID COG-ARST11B1ARST
Status Active, not recruiting
Phase N/A
First received August 17, 2011
Last updated May 8, 2015
Start date August 2011

Study information
Verified date May 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 170
Est. completion date
Est. primary completion date January 2100
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA methylation analysis

• microarray analysis

• polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Panel of hypermethylation assays for minimal disseminated RMS No
Primary Detection of RMS cells in bone marrow No
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