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Studying Biomarkers in Samples From Patients With Rhabdomyosarcoma

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ClinicalTrials.gov Identifier: NCT01433237
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : May 19, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
Sarcoma Genetic: RNA analysis Genetic: gene expression analysis Other: laboratory biomarker analysis

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.


Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective Study on the Diagnostic Value of Serum miR-206 in Rhabdomyosarcoma
Study Start Date : September 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Serum miR-206 as a biomarker for RMS

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01433237     History of Changes
Other Study ID Numbers: ARST12B1
COG-ARST12B1 ( Other Identifier: Children's Oncology Group )
ARST12B1 ( Other Identifier: Children's Oncology Group )
NCI-2011-03457 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016

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