Study of Tissue and Blood Samples From Patients With Low-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT01004523|
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : July 18, 2016
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.
|Condition or disease||Intervention/treatment|
|Brain and Central Nervous System Tumors||Genetic: fluorescence in situ hybridization Genetic: loss of heterozygosity analysis Genetic: polymerase chain reaction Other: flow cytometry Other: immunohistochemistry staining method|
- 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 Type :||Observational|
|Actual Enrollment :||135 participants|
|Official Title:||Diagnostic and Prognostic Markers in Low-Grade Gliomas|
|Study Start Date :||December 1995|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Previously preserved paraffin-embedded tissue blocks are obtained and used for biomarker studies. Blood samples obtained during treatment are also obtained. Loss of heterozygosity of specific chromosomal regions are performed using PCR analysis of microsatellite repeats (41,118-120) on DNA extracted from the paraffin-embedded archival specimens. FISH and flow cytometry may also be used to assess chromosomal loss of deletion. Immunohistochemistry is also performed.
Genetic: fluorescence in situ hybridization
Genetic: loss of heterozygosity analysis
Genetic: polymerase chain reaction
Other: flow cytometry
Other: immunohistochemistry staining method
- Alterations in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH [ Time Frame: baseline ]
- Loss of chromosomal materials in chromosomes 9p, 10, 13, 17, or 22 by PCR analysis [ Time Frame: baseline ]
- Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies [ Time Frame: baseline ]
- DNA ploidy by FISH and flow cytometry [ Time Frame: baseline ]
- Percentage of cells in S-phase or G2M-phase as measured by flow cytometry [ 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): NCT01004523
|Study Chair:||Jan Buckner, MD||Mayo Clinic|