Validation of a Multi-gene Test for Lung Cancer Risk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 403
- Locations
- 13
- Primary Endpoint
- Accuracy of LCRT to predict incidental lung cancer
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported