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

NCT ID: NCT01004887

Last Updated: 2019-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

631 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-11-30

Study Completion Date

2019-01-15

Brief Summary

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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

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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.

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

diagnostic laboratory biomarker analysis

Intervention Type OTHER

Interventions

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diagnostic laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Buckner, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Site Status

Illinois CancerCare - Bloomington

Bloomington, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Illinois CancerCare - Canton

Canton, Illinois, United States

Site Status

Illinois CancerCare - Carthage

Carthage, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Illinois CancerCare - Eureka

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Illinois CancerCare - Galesburg

Galesburg, Illinois, United States

Site Status

Illinois CancerCare - Havana

Havana, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Illinois CancerCare - Macomb

Macomb, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Moline, Illinois, United States

Site Status

Moline, Illinois, United States

Site Status

Illinois CancerCare - Monmouth

Monmouth, Illinois, United States

Site Status

OSF Holy Family Medical Center

Monmouth, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Illinois CancerCare - Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Illinois CancerCare - Pekin

Pekin, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois CancerCare - Peru

Peru, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Illinois CancerCare - Princeton

Princeton, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, United States

Site Status

Bettendorf, Iowa, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, United States

Site Status

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

Site Status

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

Site Status

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, United States

Site Status

Foote Memorial Hospital

Jackson, Michigan, United States

Site Status

Sparrow Regional Cancer Center

Lansing, Michigan, United States

Site Status

St. Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Community Cancer Center of Monroe

Monroe, Michigan, United States

Site Status

Mercy Memorial Hospital - Monroe

Monroe, Michigan, United States

Site Status

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

Site Status

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, United States

Site Status

St. John Macomb Hospital

Warren, Michigan, United States

Site Status

MeritCare Bemidji

Bemidji, Minnesota, United States

Site Status

Duluth Clinic Cancer Center - Duluth

Duluth, Minnesota, United States

Site Status

CCOP - Duluth

Duluth, Minnesota, United States

Site Status

Miller - Dwan Medical Center

Duluth, Minnesota, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, United States

Site Status

Coborn Cancer Center

Saint Cloud, Minnesota, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Bismarck Cancer Center

Bismarck, North Dakota, United States

Site Status

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, United States

Site Status

Mid Dakota Clinic, PC

Bismarck, North Dakota, United States

Site Status

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, United States

Site Status

MeritCare Broadway

Fargo, North Dakota, United States

Site Status

CCOP - MeritCare Hospital

Fargo, North Dakota, United States

Site Status

Roger Maris Cancer Center at MeritCare Hospital

Fargo, North Dakota, United States

Site Status

Wood County Oncology Center

Bowling Green, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States

Site Status

CCOP - Columbus

Columbus, Ohio, United States

Site Status

Grant Medical Center Cancer Care

Columbus, Ohio, United States

Site Status

Mount Carmel Health - West Hospital

Columbus, Ohio, United States

Site Status

Doctors Hospital at Ohio Health

Columbus, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Community Cancer Center

Elyria, Ohio, United States

Site Status

Hematology Oncology Center

Elyria, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

Northwest Ohio Oncology Center

Maumee, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, United States

Site Status

St. Charles Mercy Hospital

Oregon, Ohio, United States

Site Status

Toledo Clinic - Oregon

Oregon, Ohio, United States

Site Status

Southern Ohio Medical Center Cancer Center

Portsmouth, Ohio, United States

Site Status

North Coast Cancer Care, Incorporated

Sandusky, Ohio, United States

Site Status

Community Hospital of Springfield and Clark County

Springfield, Ohio, United States

Site Status

Flower Hospital Cancer Center

Sylvania, Ohio, United States

Site Status

Mercy Hospital of Tiffin

Tiffin, Ohio, United States

Site Status

Toledo Hospital

Toledo, Ohio, United States

Site Status

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

Medical University of Ohio Cancer Center

Toledo, Ohio, United States

Site Status

CCOP - Toledo Community Hospital

Toledo, Ohio, United States

Site Status

St. Anne Mercy Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, United States

Site Status

Genesis - Good Samaritan Hospital

Zanesville, Ohio, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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NCCTG-947252

Identifier Type: -

Identifier Source: secondary_id

CDR0000406625

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2009-00688

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-94-72-52

Identifier Type: -

Identifier Source: org_study_id

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