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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Diagnostic and Prognostic Markers in Low-Grade Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004523
• Other study ID #: NCCTG-94-72-53
• Secondary ID: NCCTG-947253CDR0
• Status: Completed
• Phase: N/A
• First received: October 29, 2009
• Last updated: July 15, 2016
• Start date: December 1995
• Est. completion date: March 2013

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

PURPOSE: This research study is looking at tissue and blood samples from patients with low-grade glioma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioma
• Nervous System Neoplasms

Intervention

Genetic:
• fluorescence in situ hybridization

• loss of heterozygosity analysis

• polymerase chain reaction

Other:
• flow cytometry

• immunohistochemistry staining method

Locations

Country	Name	City	State
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	MeritCare Bemidji	Bemidji	Minnesota
United States	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Medical Oncology and Hematology Associates - West Des Moines	Clive	Iowa
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa
United States	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	Essentia Health - Duluth Clinic	Duluth	Minnesota
United States	Miller - Dwan Medical Center	Duluth	Minnesota
United States	Community Cancer Center	Elyria	Ohio
United States	Hematology Oncology Center	Elyria	Ohio
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	MeritCare Broadway	Fargo	North Dakota
United States	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Lima Memorial Hospital	Lima	Ohio
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital - Monroe	Monroe	Michigan
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Anne Mercy Hospital	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Fulton County Health Center	Wauseon	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alterations in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH		baseline	No
Primary	Loss of chromosomal materials in chromosomes 9p, 10, 13, 17, or 22 by PCR analysis		baseline	No
Primary	Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies		baseline	No
Primary	DNA ploidy by FISH and flow cytometry		baseline	No
Primary	Percentage of cells in S-phase or G2M-phase as measured by flow cytometry		baseline	No