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

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ClinicalTrials.gov Identifier: NCT01004887
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date October 29, 2009
First Posted Date October 30, 2009
Last Update Posted Date January 17, 2019
Actual Study Start Date November 1995
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2016)
  • time to progression [ Time Frame: baseline ]
  • survival [ Time Frame: baseline ]
Original Primary Outcome Measures
 (submitted: October 29, 2009)
  • Diagnostic and prognostic relevance and value of various tumor markers in high-grade glioma
  • 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
  • DNA ploidy by flow cytometric analysis
  • Markers of cellular proliferation and cellular function including flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of PCNA, Ki-67, and p53
  • Additional markers identified by the Glioma Markers Network
  • 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
  • Comparison of the ploidy determinations by FISH and flow cytometry
Change History Complete list of historical versions of study NCT01004887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Tissue and Blood Samples From Patients With High-Grade Glioma
Official Title Diagnostic And Prognostic Markers In High-Grade Glioma
Brief Summary

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.

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and tissue
Sampling Method Probability Sample
Study Population Patients with newly diagnosed high-grade gliomas participating in NCCTG/Alliance or Mayo protocols.
Condition Brain and Central Nervous System Tumors
Intervention Other: diagnostic laboratory biomarker analysis
Study Groups/Cohorts 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.
Intervention: Other: diagnostic laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 16, 2019)
631
Original Enrollment Not Provided
Actual Study Completion Date January 15, 2019
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01004887
Other Study ID Numbers NCCTG-94-72-52
NCCTG-947252
CDR0000406625 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2009-00688 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Jan Buckner, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date January 2019