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

NCT ID: NCT01004523

Last Updated: 2016-07-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-12-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain and Central Nervous System Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

fluorescence in situ hybridization

Intervention Type GENETIC

loss of heterozygosity analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

flow cytometry

Intervention Type OTHER

immunohistochemistry staining method

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fluorescence in situ hybridization

Intervention Type GENETIC

loss of heterozygosity analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

flow cytometry

Intervention Type OTHER

immunohistochemistry staining method

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan Buckner, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Medical Oncology and Hematology Associates - West Des Moines

Clive, Iowa, United States

Site Status

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Site Status

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, United States

Site Status

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Hickman Cancer Center at Bixby Medical Center

Adrian, 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

MeritCare Bemidji

Bemidji, Minnesota, United States

Site Status

Essentia Health - Duluth Clinic

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

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

Wood County Oncology Center

Bowling Green, Ohio, United States

Site Status

Community Cancer Center

Elyria, Ohio, United States

Site Status

Hematology Oncology Center

Elyria, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Northwest Ohio Oncology Center

Maumee, Ohio, United States

Site Status

St. Charles Mercy Hospital

Oregon, Ohio, United States

Site Status

Toledo Clinic - Oregon

Oregon, 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

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCCTG-947253

Identifier Type: -

Identifier Source: secondary_id

CDR0000406626

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2009-00689

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-94-72-53

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biology Studies of Hematologic Cancers
NCT00923442 ENROLLING_BY_INVITATION