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OpenTrials
Completed

NCT Number: NCT01004523

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

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.

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Key information

Conditions

Brain and Central Nervous System Tumors Astrocytoma Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Oligodendroglioma

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Scottsdale, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Paraffin-embedded tumor tissue blocks of patients enrolled in NCCTG 86-72-51 or 93-72-02 and who had the diagnosis of low-grade glioma.
  • Patients who have the diagnosis of low-grade glioma with an available paraffin- embedded tumor tissue block enrolled in prospective NCCTG and Mayo studies.

Treatment and study plan

fluorescence in situ hybridization

Genetic

loss of heterozygosity analysis

Genetic

polymerase chain reaction

Genetic

flow cytometry

Other

immunohistochemistry staining method

Other

Primary outcomes

  1. Alterations in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH

    Time frame: baseline

  2. Loss of chromosomal materials in chromosomes 9p, 10, 13, 17, or 22 by PCR analysis

    Time frame: baseline

  3. Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies

    Time frame: baseline

  4. DNA ploidy by FISH and flow cytometry

    Time frame: baseline

  5. Percentage of cells in S-phase or G2M-phase as measured by flow cytometry

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Diagnostic and Prognostic Markers in Low-Grade Gliomas

Important dates

Study start
1995
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2009
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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