Validation of a Multi-gene Test for Lung Cancer Risk

This study is currently recruiting participants.
Verified March 2012 by University of Toledo Health Science Campus
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Willey, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT01130285
First received: May 24, 2010
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.


Condition Intervention
Lung Cancer
Genetic: Lung Cancer Risk Test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of a Multi-gene Test for Lung Cancer Risk

Resource links provided by NLM:


Further study details as provided by University of Toledo Health Science Campus:

Estimated Enrollment: 785
Study Start Date: May 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non Lung Cancer Heavy Smoker
Subjects will be ≥ 50 years of age and have a ≥ 20 pack year smoking history and will be either healthy volunteers or individuals undergoing diagnostic bronchoscopy.
Genetic: Lung Cancer Risk Test
Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.
Other Name: LCRT

Detailed Description:

Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of subjects aged 50 to 90 and with 20 or more pack year smoking history who have clinical need for diagnostic bronchoscopy (e.g. they may present with respiratory symptoms or abnormal test results consistent with the need for bronchoscopy) but are determined not to have lung cancer at the time of enrollment or within three months after the date of enrollment.

Criteria

Inclusion Criteria:

  • 20 or more pack year smoking history
  • clinical need for diagnostic bronchoscopy

Exclusion Criteria:

  • Lung Cancer within 3 months after the date of enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130285

Contacts
Contact: James Willey, MD 419.383.3543 james.willey2@utoledo.edu

Locations
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Elizabeth Klopper    303-398-1414    kloppere@njhealth.org   
Principal Investigator: Ali Musani, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Barbara Torretti    734-936-9875    btorret@med.umich.edu   
Principal Investigator: Doug Ardenberg, MD         
Henry Ford Recruiting
Detroit, Michigan, United States, 48202
Contact: Deborah Emmer    313-874-6267    demmer1@hfhs.org   
Principal Investigator: Javier Diaz-Mendoza, MD         
Sub-Investigator: Albert Levin         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Cindy Beinhorn    507-538-0595    beinhorn.cynthia@mayo.edu   
Principal Investigator: David Midthun, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Misty Edmisten    216-444-5023    edmistm@ccf.org   
Principal Investigator: Peter Mazzone, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Anita Kapil    614-366-1388    Anita.kapil@osumc.edu   
Principal Investigator: Patrick Nana-Sinkam, MD         
University of Toledo, Health Science Campus Recruiting
Toledo, Ohio, United States, 43614
Contact: Adele Griffin    419-383-6919    adele.griffin@utoledo.edu   
Principal Investigator: James Willey, MD         
The Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Lani Brighton    419-291-2373    lani.brighton@promedica.org   
Principal Investigator: Ron Wainz, MD         
Mercy St. Vincent Medical Center Recruiting
Toledo, Ohio, United States, 43608
Contact: Dee Tilley    419-251-4919    dee_tilley@mhsnr.org   
Principal Investigator: James Tita, DO         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Kalon Eways    843-792-3167    eways@musc.edu   
Principal Investigator: Gerald Silvestri, MD         
United States, Tennessee
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact: Willie Hudson    615-936-5804    willie.j.hudson@vanderbilt.edu   
Principal Investigator: Pierre Massion, MD         
Tennessee Valley Veterans Admin. Recruiting
Nashville, Tennessee, United States, 37232
Contact: Willie Hudson    615-936-5804    willie.j.hudson@vanderbilt.edu   
Principal Investigator: Pierre Massion, MD         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Mary Smith    703-776-7128    marya.smith@inova.org   
Principal Investigator: Steven Nathan, MD         
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
Principal Investigator: James Willey, MD University of Toledo Health Science Campus
  More Information

No publications provided

Responsible Party: James Willey, Principal Investigator, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT01130285     History of Changes
Other Study ID Numbers: UTHSC - 11, 1RC2CA148572-01
Study First Received: May 24, 2010
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Toledo Health Science Campus:
Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014