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Validation of a Multi-gene Test for Lung Cancer Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01130285
Recruitment Status : Active, not recruiting
First Posted : May 25, 2010
Last Update Posted : December 8, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Toledo Health Science Campus

Brief Summary:
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 or disease Intervention/treatment
Lung Cancer Genetic: Lung Cancer Risk Test

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.

Study Type : Observational
Actual Enrollment : 403 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Multi-gene Test for Lung Cancer Risk
Study Start Date : May 2011
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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, with absence of lung cancer documented at the time of enrollment.
Genetic: Lung Cancer Risk Test
Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.
Other Name: LCRT

Primary Outcome Measures :
  1. Accuracy of LCRT to predict incidental lung cancer [ Time Frame: from time of enrollment ]
    Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).

Biospecimen Retention:   Samples With DNA
Normal bronchial epithelial cell (NBEC) RNA. NBEC samples were obtained by bronchoscopic brushing after informed consent to this project was obtained. RNA was extracted and frozen in aliquots then archived. Two aliquots, were prepared for most subjects. In most cases, there were more than 1 microgram of RNA per aliquot.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 are determined not to have lung cancer at the time of enrollment or within three months after the date of enrollment, and either a) volunteer for the study driven bronchoscopy, or b) have standard of care clinical need for diagnostic bronchoscopy (e.g. they may present with respiratory symptoms or abnormal test results consistent with the need for bronchoscopy).

Inclusion Criteria:

  • 20 or more pack year smoking history
  • clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy

Exclusion Criteria:

  • Lung Cancer within 3 months after the date of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
The Toledo Hospital
Toledo, Ohio, United States, 43606
Mercy St. Vincent Medical Center
Toledo, Ohio, United States, 43608
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
National Cancer Institute (NCI)
Principal Investigator: James Willey, MD University of Toledo Health Science Campus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT01130285     History of Changes
Other Study ID Numbers: UTHSC - 11
1RC2CA148572-01 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

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
Lung Diseases
Respiratory Tract Diseases