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Clinical Trials/NCT01004523
NCT01004523
Completed
Not Applicable

Diagnostic and Prognostic Markers in Low-Grade Gliomas

Alliance for Clinical Trials in Oncology38 sites in 1 country135 target enrollmentDecember 1995

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain and Central Nervous System Tumors
Sponsor
Alliance for Clinical Trials in Oncology
Enrollment
135
Locations
38
Primary Endpoint
Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer 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 predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue and blood samples from patients with low-grade glioma.

Detailed Description

OBJECTIVES: * Evaluate the diagnostic and prognostic relevance of alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y, using PCR analysis of microsatellite repeats and FISH. * Evaluate the diagnostic and prognostic relevance of DNA ploidy by flow cytometric analysis; compare with ploidy determination by FISH. * Assess the diagnostic and prognostic relevance of various markers of cellular proliferation and cellular function including flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of PCNA, Ki-67, and p53.

Registry
clinicaltrials.gov
Start Date
December 1995
End Date
March 2013
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies

Time Frame: baseline

DNA ploidy by FISH and flow cytometry

Time Frame: baseline

Alterations in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH

Time Frame: baseline

Loss of chromosomal materials in chromosomes 9p, 10, 13, 17, or 22 by PCR analysis

Time Frame: baseline

Percentage of cells in S-phase or G2M-phase as measured by flow cytometry

Time Frame: baseline

Study Sites (38)

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