Biomarkers in Tissue Samples From Patients With Ewing Sar... | NCT01480518

Studies
Biomarkers in Tissue Samples From Patients With Ewing Sarcoma

NCT01480518

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 12, 2015Estimated

Enrollment

166Actual

Phase

Not provided

Conditions

Sarcoma

Interventions

DNA analysis
comparative genomic hybridization
gene expression analysis
mutation analysis
polymerase chain reaction
polymorphic microsatellite marker 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-AEWS11B2	Other Identifier	Children's Oncology Group
AEWS11B2	Other Identifier	Children's Oncology Group
NCI-2012-00083	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

May 2015

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

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Nov 22, 2011

First Submission Date that Met QC Criteria

Nov 28, 2011

First Posted Date

Nov 29, 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 8, 2015

Last Update Posted Date

May 12, 2015Estimated

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 in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with Ewing sarcoma.

Detailed Description

OBJECTIVES:

To describe the spectrum of GGAA-microsatellite polymorphisms at specific loci in genomic DNA prepared from Ewing sarcoma tumor specimens.
To determine if there are differences in GGAA-microsatellite polymorphisms in genomic DNA prepared from Ewing sarcoma tumor specimens as compared to non-afflicted European and African normal genomic DNA.
To determine if GGAA-microsatellite polymorphisms at specific loci in genomic DNA prepared from Ewing's sarcoma tumor specimens correlates with disease outcome in patients treated on COG protocol AEWS0031.
To determine whether whole-genome amplification introduces alterations in GGAA-microsatellites as compared to non-amplified genomic DNA.

OUTLINE: Genomic PCR is used to amplify the microsatellites in the NR0B1 and GSTM4 promoters. In addition to determining microsatellite size, each microsatellite is sequenced following cloning into the pCR4 vector (Invitrogen) using standard topoisomerase cloning protocols.

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

166Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA analysis	Genetic
comparative genomic hybridization	Genetic
gene expression analysis	Genetic
mutation analysis	Genetic
polymerase chain reaction	Genetic
polymorphic microsatellite marker analysis	Genetic
laboratory biomarker analysis	Other

Measure	Description	Time Frame
Event-free survival

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Specimens from patients with Ewing sarcoma used for protocol COG-AEWS08B1
- Obtained from patient samples taken from patients enrolled on COG-AEWS0031
- Whole genome-amplified DNA will be used

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

50 Years

Standard Ages

ChildAdult

Study Population

Ewing sarcoma.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Stephen Lessnick, MD, PhD	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
D055028	Comparative Genomic Hybridization
D020869	Gene Expression Profiling
D016133	Polymerase Chain Reaction

Ancestor Terms

ID	Term
D020732	Cytogenetic Analysis
D005821	Genetic Techniques
D008919	Investigative Techniques
D025202	Molecular Diagnostic Techniques

Browse Leaves

Not provided

Browse Branches

Not provided