A Prospective Pilot Study of Lung Cancer Screening in Patients at High Risk for Lung Cancer Who Do Not Meet Current Screening Guidelines
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- University of Colorado, Denver
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Economic Outcomes
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.
Detailed Description
This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Potential subject's 6 yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult 40-82 yrs of age.
- •Presenting for lung cancer screening evaluation.
- •Calculated 6 yr lung cancer risk \>1.5% for patients 40-77 years of age or \>4% for patients 78-82 years of age.
- •Able and willing to provide informed consent.
Exclusion Criteria
- •Eligible for clinically indicated lung cancer screening (55-80 yr old, \>30 pky smoking history, still smoking or quit smoking within the last 15 yr).
- •Chest CT performed within the last year.
- •Life expectancy less than 6 months.
- •Symptoms clinically consistent with lung cancer.
- •Unable or unwilling to undergo treatment for lung cancer.
- •Any individual who does not give oral and written consent for participation.
Outcomes
Primary Outcomes
Economic Outcomes
Time Frame: Duration of the study, up to 3 years
Evaluate the costs associated with managing the spectrum of other radiographic abnormalities
Lung Cancer Screening
Time Frame: Duration of the study, up to 3 years
Prospectively identify patients for lung cancer screening using risk calculators
Medical Outcomes
Time Frame: Duration of the study, up to 3 years
Evaluate health outcomes of CT screening by assessing the number and stage the spectrum of other radiographic abnormalities detected using Lung-RADS criteria