Biomarkers in Tissue Samples From Patients With Ewing Sarcoma

May 8, 2015 updated by: Children's Oncology Group

Analysis of GGAA-Microsatellites in Ewing Sarcoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ewing sarcoma.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Event-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Stephen Lessnick, MD, PhD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (ESTIMATE)

November 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 8, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEWS11B2 (OTHER: Children's Oncology Group)
  • COG-AEWS11B2 (OTHER: Children's Oncology Group)
  • NCI-2012-00083 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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