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Biomarkers in Tissue Samples From Patients With Ewing Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01480518
First received: November 22, 2011
Last updated: December 23, 2011
Last verified: December 2011
History of Changes

November 22, 2011
December 23, 2011
December 2011
January 2012   (final data collection date for primary outcome measure)
Event-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01480518 on ClinicalTrials.gov Archive Site
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Biomarkers in Tissue Samples From Patients With Ewing Sarcoma
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.

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.
Observational
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
166
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January 2012   (final data collection date for primary outcome measure)

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
Both
up to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01480518
CDR0000717540, COG-AEWS11B2
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Peter C. Adamson, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Stephen Lessnick, MD, PhD University of Utah
National Cancer Institute (NCI)
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP