Study of Tissue and Blood Samples From Patients With High-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT01004887|
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : January 17, 2019
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.
|Condition or disease||Intervention/treatment|
|Brain and Central Nervous System Tumors||Other: diagnostic laboratory biomarker analysis|
- 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 Type :||Observational|
|Actual Enrollment :||631 participants|
|Official Title:||Diagnostic And Prognostic Markers In High-Grade Glioma|
|Actual Study Start Date :||November 1995|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||January 15, 2019|
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.
Other: diagnostic laboratory biomarker analysis
- time to progression [ Time Frame: baseline ]
- survival [ Time Frame: baseline ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004887
Show 110 Study Locations
|Study Chair:||Jan Buckner, MD||Mayo Clinic|