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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


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
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