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

January 16, 2019 updated by: Alliance for Clinical Trials in Oncology

Diagnostic And Prognostic Markers In High-Grade Glioma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

631

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic Scottsdale
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Illinois CancerCare - Bloomington
      • Bloomington, Illinois, United States, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare - Canton
      • Canton, Illinois, United States, 61520
        • Graham Hospital
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare - Carthage
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare - Eureka
      • Eureka, Illinois, United States, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare - Galesburg
      • Galesburg, Illinois, United States, 61401
        • Galesburg Clinic, PC
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Havana, Illinois, United States, 62644
        • Illinois CancerCare - Havana
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare - Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare - Macomb
      • Macomb, Illinois, United States, 61455
        • Mcdonough District Hospital
      • Moline, Illinois, United States, 61265
      • Moline, Illinois, United States, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
      • Monmouth, Illinois, United States, 61462
        • Illinois CancerCare - Monmouth
      • Monmouth, Illinois, United States, 61462
        • OSF Holy Family Medical Center
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, United States, 61761
        • Community Cancer Center
      • Normal, Illinois, United States, 61761
        • Illinois CancerCare - Community Cancer Center
      • Ottawa, Illinois, United States, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, United States, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, United States, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Pekin, Illinois, United States, 61603
        • Illinois CancerCare - Pekin
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, United States, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare - Peru
      • Peru, Illinois, United States, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare - Princeton
      • Spring Valley, Illinois, United States, 61362
        • Illinois CancerCare - Spring Valley
    • Iowa
      • Bettendorf, Iowa, United States, 52722
      • Cedar Rapids, Iowa, United States, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51102
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Dearborn, Michigan, United States, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Jackson, Michigan, United States, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, United States, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, United States, 48154
        • St. Mary Mercy Hospital
      • Monroe, Michigan, United States, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital - Monroe
      • Pontiac, Michigan, United States, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, United States, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • MeritCare Bemidji
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, United States, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, United States, 55805
        • Miller - Dwan Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, United States, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, United States, 58102
        • MeritCare Broadway
      • Fargo, North Dakota, United States, 58122
        • Roger Maris Cancer Center at MeritCare Hospital
    • Ohio
      • Bowling Green, Ohio, United States, 43402
        • Wood County Oncology Center
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center Cancer Care
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital at Ohio Health
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Elyria, Ohio, United States, 44035
        • Community Cancer Center
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Marietta, Ohio, United States, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee, Ohio, United States, 43537-1839
        • Northwest Ohio Oncology Center
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Oregon, Ohio, United States, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic - Oregon
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center Cancer Center
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care, Incorporated
      • Springfield, Ohio, United States, 45505
        • Community Hospital of Springfield and Clark County
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, United States, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, United States, 43623
        • St. Anne Mercy Hospital
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Westerville, Ohio, United States, 43081
        • Mount Carmel St. Ann's Cancer Center
      • Zanesville, Ohio, United States, 43701
        • Genesis - Good Samaritan Hospital
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology, Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with newly diagnosed high-grade gliomas participating in NCCTG/Alliance or Mayo protocols.

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to progression
Time Frame: baseline
baseline
survival
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 1995

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Actual)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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