Validation of a Multi-gene Test for Lung Cancer Risk

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 Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: 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
• Enrollment (Actual): 403

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43221
      • Ohio State University
    • Toledo, Ohio, United States, 43606
      • The Toledo Hospital
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent Medical Center
    • Toledo, Ohio, United States, 43614
      • University of Toledo, Health Science Campus
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt
    • Nashville, Tennessee, United States, 37232
      • Tennessee Valley Veterans Admin.
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: LCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of LCRT to predict incidental lung cancer	Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).	from time of enrollment

Collaborators and Investigators

• Sponsor: University of Toledo Health Science Campus
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: James Willey, MD, University of Toledo Health Science Campus

Publications and helpful links

General Publications

• Crawford EL, Levin A, Safi F, Lu M, Baugh A, Zhang X, Yeo J, Khuder SA, Boulos AM, Nana-Sinkam P, Massion PP, Arenberg DA, Midthun D, Mazzone PJ, Nathan SD, Wainz R, Silvestri G, Tita J, Willey JC. Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a biospecimen repository. BMC Pulm Med. 2016 Jan 22;16:16. doi: 10.1186/s12890-016-0178-4.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: May 24, 2010
• First Posted (Estimated): May 25, 2010

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Lung Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: UTHSC - 11; 1RC2CA148572-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes