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

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT01004887
• 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 high-grade glioma.

Detailed Description

OBJECTIVES:

* To evaluate the diagnostic and prognostic relevance of various molecular, cytogenetic, and other tumor markers in high-grade glioma in paraffin-embedded tissue collected from patients enrolled in the Mayo Clinic or North Central Cancer Treatment Group (NCCTG) high-grade glioma trials conducted since 1979.

* To evaluate 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.

* To determine DNA ploidy by flow cytometric analysis.

* To examine 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.

* To evaluate additional markers identified by the Glioma Markers Network.

* To compare the incidence of markers in the major histologic subtypes (anaplastic astrocytoma \[AA\], anaplastic oligoastrocytoma \[AOA\], glioblastoma multiforme \[GBM\]) and to assess their correlation in the total group, as well as within each of these subtypes.

* To compare the ploidy determinations by FISH and flow cytometry.

OUTLINE: Paraffin-embedded tissue and peripheral blood samples, previously or currently collected from clinical trials participants at the time she/he enrolled in the trial, are evaluated for as many markers as possible, changes in cytogenic and molecular genetic tumor markers, frequency distributions of all tumor markers and histological and clinical variables by polymerase chain reaction, IHC, flow cytometry, and FISH analysis.

Study Timeline

• Study Start: 1995-11
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Primary Completion: 2014-12
• Status Verified: 2019-01
• Study Completion: 2019-01-15
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 631

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survival	baseline
time to progression	baseline

Trial Locations

Locations (107)

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

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center; 🇺🇸 Hartford, Connecticut, United States

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

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center; 🇺🇸 Boise, Idaho, United States

Illinois CancerCare - Bloomington; 🇺🇸 Bloomington, Illinois, United States

St. Joseph Medical Center; 🇺🇸 Bloomington, Illinois, United States

Graham Hospital; 🇺🇸 Canton, Illinois, United States

Illinois CancerCare - Canton; 🇺🇸 Canton, Illinois, United States

Illinois CancerCare - Carthage; 🇺🇸 Carthage, Illinois, United States

Memorial Hospital; 🇺🇸 Carthage, Illinois, United States

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