Studying Biomarkers in Samples From Patients With Rhabdom... | NCT01433237

Studies
Studying Biomarkers in Samples From Patients With Rhabdomyosarcoma

NCT01433237

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 19, 2016Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Sarcoma

Interventions

RNA analysis
gene expression analysis
laboratory biomarker analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
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)

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Sep 9, 2011

First Submission Date that Met QC Criteria

Sep 9, 2011

First Posted Date

Sep 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2016

Last Update Posted Date

May 19, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Measure	Description	Time Frame
Serum miR-206 as a biomarker for RMS

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hajime Hosoi, MD	Kyoto Prefectural University of Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma
D012208	Rhabdomyosarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009217	Myosarcoma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020869	Gene Expression Profiling

Ancestor Terms

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
RNA analysis	Genetic
gene expression analysis	Genetic
laboratory biomarker analysis	Other