Validation of a Multi-gene Test for Lung Cancer Risk
2 other identifiers
observational
403
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2011
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
May 25, 2010
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
June 10, 2025
June 1, 2025
15.3 years
May 24, 2010
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.
Eligibility Criteria
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).
You may qualify if:
- or more pack year smoking history
- clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy
You may not qualify if:
- Lung Cancer within 3 months after the date of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
National Jewish Health
Denver, Colorado, 80206, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43221, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608, United States
University of Toledo, Health Science Campus
Toledo, Ohio, 43614, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Tennessee Valley Veterans Admin.
Nashville, Tennessee, 37232, United States
Vanderbilt
Nashville, Tennessee, 37232, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Related Publications (1)
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.
PMID: 26801409BACKGROUND
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Willey, MD
University of Toledo Health Science Campus
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2010
First Posted
May 25, 2010
Study Start
May 1, 2011
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share