Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Validation of a Multi-gene Test for Lung Cancer Risk

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
James Willey, University of Toledo Health Science Campus Identifier:
First received: May 24, 2010
Last updated: May 23, 2014
Last verified: May 2014

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:

Primary Outcome Measures:
  • Accuracy of LCRT to predict incidental lung cancer [ Time Frame: from time of enrollment ] [ Designated as safety issue: No ]
    Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).

Estimated Enrollment: 785
Study Start Date: May 2011
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: August 2018 (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.


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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01130285

United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43221
Mercy St. Vincent Medical Center
Toledo, Ohio, United States, 43608
The Toledo Hospital
Toledo, Ohio, United States, 43606
University of Toledo, Health Science Campus
Toledo, Ohio, United States, 43614
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Tennessee Valley Veterans Admin.
Nashville, Tennessee, United States, 37232
Nashville, Tennessee, United States, 37232
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
University of Toledo Health Science Campus
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 Identifier: NCT01130285     History of Changes
Other Study ID Numbers: UTHSC - 11, 1RC2CA148572-01
Study First Received: May 24, 2010
Last Updated: May 23, 2014
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
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on February 26, 2015