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Biomarkers in Tissue Samples From Patients With Ewing Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480518
First Posted: November 29, 2011
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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.


Condition Intervention
Sarcoma Genetic: DNA analysis Genetic: comparative genomic hybridization Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: polymorphic microsatellite marker analysis Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Analysis of GGAA-Microsatellites in Ewing Sarcoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival

Biospecimen Retention:   Samples With DNA
Tissue

Enrollment: 166
Study Start Date: December 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ewing sarcoma.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480518


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen Lessnick, MD, PhD University of Utah
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01480518     History of Changes
Other Study ID Numbers: AEWS11B2
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) )
First Submitted: November 22, 2011
First Posted: November 29, 2011
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Children's Oncology Group:
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue