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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01004523
First received: October 29, 2009
Last updated: July 15, 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 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
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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 in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Loss of chromosomal materials in chromosomes 9p, 10, 13, 17, or 22 by PCR analysis [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • DNA ploidy by FISH and flow cytometry [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Percentage of cells in S-phase or G2M-phase as measured by flow cytometry [ Time Frame: baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
tissue and blood samples

Enrollment: 135
Study Start Date: December 1995
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single group
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.
Genetic: fluorescence in situ hybridization Genetic: loss of heterozygosity analysis Genetic: polymerase chain reaction Other: flow cytometry Other: immunohistochemistry staining method

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with low grade glioma.
Criteria
  1. 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.
  2. Patients who have the diagnosis of low-grade glioma with an available paraffin- embedded tumor tissue block enrolled in prospective NCCTG and Mayo studies.
  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
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: 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, 2016
Health Authority: United States: Institutional Review Board

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 December 09, 2016