Biomarkers in Tumor Tissue Samples From Younger Patients... | NCT01496573

Studies
Biomarkers in Tumor Tissue Samples From Younger Patients With Rhabdomyosarcoma

NCT01496573

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 19, 2016Estimated

Enrollment

77Actual

Phase

Not provided

Conditions

Alveolar Childhood Rhabdomyosarcoma
Childhood Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma

Interventions

laboratory biomarker analysis

Countries

United States

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	Link
NCI-2012-00094	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

Dec 2011

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Dec 16, 2011

First Submission Date that Met QC Criteria

Dec 17, 2011

First Posted Date

Dec 21, 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

This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Detailed Description

PRIMARY OBJECTIVES:

I. To demonstrate CRKL expression at the protein level in rhabdomyosarcoma tumors by tissue microarray (TMA).

OUTLINE:

Archived tumor tissue samples are analyzed for CRKL expression.

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

Retention

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Basic science (biomarker analysis)		Archived tumor tissue samples are analyzed for CRKL expression.	Other: laboratory biomarker analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laboratory biomarker analysis	Other	Correlative studies	Basic science (biomarker analysis)

Measure	Description	Time Frame
CRKL expression at the protein level		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma specimens from the Children Oncology Group (COG) tumor microarrays (TMAs)

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

Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lee Helman, MD	Children's Oncology Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Oncology Group		Monrovia	California	91006-3776	United States