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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Brain and Central Nervous System Tumors

Treatments: Other: diagnostic laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01004887

NCCTG-94-72-52

NCI-2009-00688 (Registry Identifier)

NCCTG-947252

CDR0000406625 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 631 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Patients with newly diagnosed high-grade gliomas
• Patients participating in NCCTG/Alliance or Mayo protocols
• Willing to provide mandatory blood and tissue samples for research purposes; note: 15 unstained slides may be submitted in place of a tissue block

Trial design

631 participants in 1 patient group

Single group

Description:

Patients with newly diagnosed high-grade gliomas participating in NCCTG/Alliance or Mayo protocols. Previously collected blood and tissue samples are analyzed via PCR, IHC, flow cytometry, and FISH.

Treatment:

Other: diagnostic laboratory biomarker analysis