Studying Biomarkers in Samples From Patients With Rhabdomyosarcoma

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Children's Oncology Group

ClinicalTrials.gov Identifier:

NCT01433237

First received: September 9, 2011

Last updated: May 17, 2016

Last verified: May 2016

History of Changes

Purpose

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.

Condition	Intervention
Sarcoma	Genetic: RNA analysis Genetic: gene expression analysis Other: laboratory biomarker analysis


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	A Retrospective Study on the Diagnostic Value of Serum miR-206 in Rhabdomyosarcoma

Resource links provided by NLM:

MedlinePlus related topics: Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:

Serum miR-206 as a biomarker for RMS [ Designated as safety issue: No ]


Estimated Enrollment:	40
Study Start Date:	September 2011
Study Completion Date:	May 2016
Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Rhabdomyosarcoma (RMS), embryonal RMS, and non-RMS.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433237

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Hajime Hosoi, MD	Kyoto Prefectural University of Medicine

More Information


Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT01433237 History of Changes
Other Study ID Numbers:	ARST12B1 COG-ARST12B1 ARST12B1 NCI-2011-03457
Study First Received:	September 9, 2011
Last Updated:	May 17, 2016
Health Authority:	United States: Federal Government

Keywords provided by Children's Oncology Group:


embryonal childhood rhabdomyosarcoma adult rhabdomyosarcoma alveolar childhood rhabdomyosarcoma adult soft tissue sarcoma childhood rhabdomyosarcoma

Additional relevant MeSH terms:


Sarcoma Rhabdomyosarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type	Neoplasms Myosarcoma Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on September 27, 2016

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