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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01004887
First received: October 29, 2009
Last updated: July 11, 2016
Last verified: July 2016
  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
Other: diagnostic laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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:
  • time to progression [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • survival [ Time Frame: baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood and tissue

Estimated Enrollment: 200
Study Start Date: November 1995
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single group
Patients with newly diagnosed high-grade gliomas participating in NCCTG/Alliance or Mayo protocols. Previously collected blood and tissue samples are analyzed via PCR, IHC, flow cytometry, and FISH.
Other: diagnostic laboratory biomarker analysis

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with newly diagnosed high-grade gliomas participating in NCCTG/Alliance or Mayo protocols.
Criteria
  • Patients with newly diagnosed high-grade gliomas
  • Patients participating in NCCTG/Alliance or Mayo protocols
  • Willing to provide mandatory blood and tissue samples for research purposes; note: 15 unstained slides may be submitted in place of a tissue block
  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
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Jan Buckner, MD Mayo Clinic
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01004887     History of Changes
Other Study ID Numbers: NCCTG-94-72-52  NCCTG-947252  CDR0000406625  NCI-2009-00688 
Study First Received: October 29, 2009
Last Updated: July 11, 2016
Health Authority: United States: Institutional Review Board

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 21, 2016