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

Official Title: “Diagnostic and Prognostic Markers in Low-Grade Gliomas”

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.

OBJECTIVES: - 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.

OUTLINE: 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.

Intervention(s) in this Clinical Trial

• Genetic: fluorescence in situ hybridization
• Genetic: loss of heterozygosity analysis
• Genetic: polymerase chain reaction
• Other: flow cytometry
• Other: immunohistochemistry staining method

Primary Measures

• 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
  • Safety Issue?: No
• DNA ploidy as determined by flow cytometric analysis; compare with ploidy determination by FISH
  • Safety Issue?: No
• 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
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Diagnosis of low-grade glioma, meeting 1 of the following criteria:
• Paraffin embedded tumor tissue blocks obtained while enrolled in prospective
• NCCTG and Mayo studies available
• Paraffin-embedded tumor tissue blocks obtained while enrolled in NCCTG 86-72-51 or NCCTG 93-72-02 available

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: North Central Cancer Treatment Group Other

Overall Clinical Trial Officials and Contacts

Jan C. Buckner, MD Study Chair Mayo Clinic  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01004523

Study ID Number: CDR0000406626

ClinicalTrials.gov Identifier: NCT01004523

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database