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NCT01433237 Clinical Trial

Studying Biomarkers in Samples From Patients With Rhabdomyosarcoma

Sarcoma Clinical Trial

Official title:
A Retrospective Study on the Diagnostic Value of Serum miR-206 in Rhabdomyosarcoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01433237
Other study ID # ARST12B1
Secondary ID COG-ARST12B1ARST
Status Completed
Phase N/A
First received September 9, 2011
Last updated May 17, 2016
Start date September 2011
Est. completion date May 2016

Study information
Verified date May 2016
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: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from patients with rhabdomyosarcoma.

Description:

OBJECTIVES:

- Determine whether circulating muscle-specific microRNAs, especially serum miR-206, are potential biomarkers for rhabdomyosarcoma (RMS).

OUTLINE: Archived serum samples are analyzed for miR-206 expression.

PROJECTED ACCRUAL: A total of 15 samples from patients with alveolar rhabdomyosarcoma (RMS), 15 from patients with embryonal RMS, and 10 from patients without RMS will be accrued for this study.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Serum specimens of rhabdomyosarcoma (RMS), embryonal RMS, and non-RMS available from the Soft Tissue Sarcoma committee of Children's Oncology Group

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• RNA analysis

• gene expression analysis

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 Serum miR-206 as a biomarker for RMS No
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