Study of Tissue and Blood Samples From Patients With Low-Grade Glioma

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT01004523
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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 Timeline

• Study Start: 1995-12
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies	baseline
DNA ploidy by FISH and flow cytometry	baseline
Alterations in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH	baseline
Loss of chromosomal materials in chromosomes 9p, 10, 13, 17, or 22 by PCR analysis	baseline
Percentage of cells in S-phase or G2M-phase as measured by flow cytometry	baseline

Trial Locations

Locations (38)

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Medical Oncology and Hematology Associates - West Des Moines; 🇺🇸 Clive, Iowa, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center; 🇺🇸 Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at John Stoddard Cancer Center; 🇺🇸 Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at Mercy Cancer Center; 🇺🇸 Des Moines, Iowa, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines; 🇺🇸 Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital; 🇺🇸 Des Moines, Iowa, United States

Hickman Cancer Center at Bixby Medical Center; 🇺🇸 Adrian, Michigan, United States

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