Biomarker in Tissue Samples From Patients With Ewing Sarcoma | NCT01365949

Studies
Biomarker in Tissue Samples From Patients With Ewing Sarcoma

NCT01365949

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

Jul 11, 2016Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Sarcoma

Interventions

microarray analysis
protein analysis
immunohistochemistry staining method
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-AEWS11B1	Other Identifier	Children's Oncology Group
NCI-2011-02857	Registry Identifier	CTRP (Clinical Trial Reporting Program)
AEWS11B1	Other Identifier	Children's Oncology Group

Status Module

Record Verification Date

Jul 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

May 2011

Primary Completion Date

Jul 2016Actual

Completion Date

Not provided

First Submitted Date

Jun 1, 2011

First Submission Date that Met QC Criteria

Jun 1, 2011

First Posted Date

Jun 3, 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

Jul 7, 2016

Last Update Posted Date

Jul 11, 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 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.

PURPOSE: This research trial studies biomarkers in tissue samples from patients with Ewing sarcoma.

Detailed Description

OBJECTIVES:

To determine the frequency of INI-1 protein loss in Ewing Sarcoma.

OUTLINE: Previously collected tissue samples are analyzed for INI-1 protein loss by IHC and tissue microarray.

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

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
microarray analysis	Genetic
protein analysis	Genetic
immunohistochemistry staining method	Other
laboratory biomarker analysis	Other

Measure	Description	Time Frame
Frequency of INI1 protein loss in Ewing Sarcoma

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of Ewing sarcoma
Prepared tissue microarray with Ewing sarcoma samples available

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

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Diagnosis of Ewing sarcoma.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Joshua D. Schiffman, MD	University of Utah	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma
D018241	Neuroectodermal Tumors, Primitive, Peripheral

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018242	Neuroectodermal Tumors, Primitive

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D046228	Microarray Analysis
D007150	Immunohistochemistry

Ancestor Terms

ID	Term
D046208	Microchip Analytical Procedures
D008919	Investigative Techniques
D006651	Histocytochemistry
D003584	Cytological Techniques

Browse Leaves

Not provided

Browse Branches

Not provided