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NCT01480518 Clinical Trial

Biomarkers in Tissue Samples From Patients With Ewing Sarcoma

Sarcoma Clinical Trial

Official title:
Analysis of GGAA-Microsatellites in Ewing Sarcoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01480518
Other study ID # AEWS11B2
Secondary ID COG-AEWS11B2AEWS
Status Completed
Phase N/A
First received November 22, 2011
Last updated May 8, 2015
Start date December 2011
Est. completion date January 2012

Study information
Verified date May 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 50 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• comparative genomic hybridization

• gene expression analysis

• mutation analysis

• polymerase chain reaction

• polymorphic microsatellite marker analysis

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Event-free survival No
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