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Clinical Trials/NCT01004523
NCT01004523CompletedNot Applicable

Diagnostic and Prognostic Markers in Low-Grade Gliomas

Alliance for Clinical Trials in Oncology38 sites in 1 country135 target enrollmentStarted: December 1995Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
135
Locations
38
Primary Endpoint
Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (38)

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