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Brain and Central Nervous System TumorsNCT01004887

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

An observational study of Brain and Central Nervous System Tumors, run by Alliance for Clinical Trials in Oncology at 110 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
diagnostic laboratory biomarker analysis
How many people
631 participants
Where
110 sitesUnited States
Study dates
Nov 1995to 15 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

  • 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

Trial locations and contacts

110 sites in 1 country.

110 sites in 1 country

United States110 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Study site

    Bettendorf, Iowa, 52722

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Graham Hospital

    Canton, Illinois, 61520

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • MeritCare Broadway

    Fargo, North Dakota, 58102

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • Roger Maris Cancer Center at MeritCare Hospital

    Fargo, North Dakota, 58122

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401

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

    Grosse Pointe Woods, Michigan, 48236

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

    Hartford, Connecticut, 06105

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

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

    Moline, Illinois, 61265

  • Study site

    Moline, Illinois, 61265

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462

  • OSF Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Southern Ohio Medical Center Cancer Center

    Portsmouth, Ohio, 45662

  • Illinois CancerCare - Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51102

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Illinois CancerCare - Spring Valley

    Spring Valley, Illinois, 61362

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
diagnostic laboratory biomarker analysis
Keywords
adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma, childhood high-grade cerebellar astrocytoma, childhood high-grade cerebral astrocytoma
Medical subject headings
Central Nervous System Neoplasms, Astrocytoma, Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diagnostic laboratory biomarker analysisOther

Study groups in NCT01004887
Study groupRoleWhat they receive
Single groupPatients 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.
Receives: Other: diagnostic laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to progression

    Measured: baseline

  2. survival

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2009 (estimated)
  2. Study startNov 1995
  3. Primary completionDec 2014
  4. Study completion15 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
631 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01004887
Sponsor's protocol ID
NCCTG-94-72-52
Other IDs
NCCTG-947252, CDR0000406625, NCI-2009-00688
Status last verified
Jan 2019
First submitted
29 Oct 2009
Last updated
17 Jan 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Brain and Central Nervous System Tumors, run by Alliance for Clinical Trials in Oncology at 110 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to progression (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01004887.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.

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