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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01004523
First received: October 29, 2009
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: Diagnostic and Prognostic Markers in Low-Grade Gliomas

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome 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 [ Designated as safety issue: No ]
  • DNA ploidy as determined by flow cytometric analysis; compare with ploidy determination by FISH [ Designated as 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 [ Designated as safety issue: No ]

Enrollment: 0
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004523

  Show 38 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Jan C. Buckner, MD Mayo Clinic
Investigator: Robert M. Arusell, MD Roger Maris Cancer Center at MeritCare Hospital
Investigator: David W. Kimmel, MD Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01004523     History of Changes
Other Study ID Numbers: NCCTG-94-72-53, NCCTG-947253, CDR0000406626, NCI-2009-00689
Study First Received: October 29, 2009
Last Updated: July 15, 2013
Health Authority: Unspecified

Keywords provided by Alliance for Clinical Trials in Oncology:
childhood low-grade cerebellar astrocytoma
childhood low-grade cerebral astrocytoma
childhood mixed glioma
adult mixed glioma
adult diffuse astrocytoma
childhood oligodendroglioma
adult oligodendroglioma

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on September 14, 2014