Validation of a Multi-gene Test for Lung Cancer Risk

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2020

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.

Interventions

  • Genetic: Lung Cancer Risk Test
    • Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Toledo Health Science Campus
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James Willey, MD, Principal Investigator, University of Toledo Health Science Campus

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