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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01004887
First received: October 29, 2009
Last updated: June 27, 2013
Last verified: December 2012
  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 high-grade glioma.


Condition Intervention
Brain and Central Nervous System Tumors
Genetic: DNA ploidy analysis
Genetic: fluorescence in situ hybridization
Genetic: microsatellite instability analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
Other: flow cytometry
Other: immunohistochemistry staining method

Study Type: Observational
Official Title: Diagnostic And Prognostic Markers In High-Grade Glioma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Diagnostic and prognostic relevance and value of various tumor markers in high-grade glioma [ Designated as safety issue: No ]
  • 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 by flow cytometric analysis [ Designated as safety issue: No ]
  • 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 ]
  • Additional markers identified by the Glioma Markers Network [ Designated as safety issue: No ]
  • Incidence of markers in the major histologic subtypes (AA, AOA, GBM) and their correlation in the total group, as well as within each of these subtypes [ Designated as safety issue: No ]
  • Comparison of the ploidy determinations by FISH and flow cytometry [ Designated as safety issue: No ]

Enrollment: 0
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-grade glioma meeting 1 of the following criteria:

    • Paraffin blocks of tumor specimen submitted from patients previously enrolled in North Central Cancer Treatment Group (NCCTG) (including NCCTG-797251, NCCTG-857251, and NCCTG-887252) or Mayo Clinic studies
    • Paraffin-embedded tumor tissue blocks or 15 unstained tumor tissue slides and peripheral blood samples of patients currently enrolled or will be in the future enrolled in Mayo Clinic or NCCTG clinical trials conducted since 1979 and designed to assess specific therapies in patients with high-grade glioma
  • Must meet any of the following WHO grade 3 or 4 classification subtypes:

    • Anaplastic astrocytoma
    • Anaplastic oligoastrocytoma
    • Glioblastoma multiforme
  • Newly diagnosed disease

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: NCT01004887

  Show 110 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Paul L. Schaefer, MD Hickman Cancer Center at Bixby Medical Center
Investigator: Jan C. Buckner, MD Mayo Clinic
Investigator: David W. Kimmel, MD Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01004887     History of Changes
Other Study ID Numbers: 94-72-52, NCCTG-947252, CDR0000406625, NCI-2009-00688
Study First Received: October 29, 2009
Last Updated: June 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
childhood high-grade cerebellar astrocytoma
childhood high-grade cerebral astrocytoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014