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

Diagnostic And Prognostic Markers In High-Grade Glioma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01004887
Enrollment
631
Registered
2009-10-30
Start date
1995-11-30
Completion date
2019-01-15
Last updated
2019-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma, childhood high-grade cerebellar astrocytoma, childhood high-grade cerebral astrocytoma

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.

Interventions

OTHERdiagnostic laboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
time to progressionbaseline
survivalbaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026