Validation of a Multi-gene Test for Lung Cancer Risk
- Conditions
- Lung Cancer
- Interventions
- Genetic: Lung Cancer Risk Test
- Registration Number
- NCT01130285
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 403
- 20 or more pack year smoking history
- clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy
- Lung Cancer within 3 months after the date of enrollment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-Lung Cancer, Heavy Smoker Lung Cancer Risk Test 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.
- Primary Outcome Measures
Name Time Method Accuracy of LCRT to predict incidental lung cancer 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Mercy St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
University of Toledo, Health Science Campus
🇺🇸Toledo, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Tennessee Valley Veterans Admin.
🇺🇸Nashville, Tennessee, United States
Vanderbilt
🇺🇸Nashville, Tennessee, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Henry Ford
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States