Lung Cancer
Conditions
Keywords
Pilot Study, High Risk, Prospective, Screening
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.
Interventions
DIAGNOSTIC_TESTScreening
Subjects will undergo a low dose non contrast CT chest for lung cancer screening. The test will be performed by the UCH Radiology Department and read by board-certified chest radiologists using Lung-RADS criteria.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
1. Adult 40-82 yrs of age. 2. Presenting for lung cancer screening evaluation. 3. Calculated 6 yr lung cancer risk \>1.5% for patients 40-77 years of age or \>4% for patients 78-82 years of age. 4. Able and willing to provide informed consent.
Exclusion criteria
1. 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). 2. Chest CT performed within the last year. 3. Life expectancy less than 6 months. 4. Symptoms clinically consistent with lung cancer. 5. Unable or unwilling to undergo treatment for lung cancer. 6. Any individual who does not give oral and written consent for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Cancer Screening | Duration of the study, up to 3 years | Prospectively identify patients for lung cancer screening using risk calculators |
| Medical Outcomes | Duration of the study, up to 3 years | Evaluate health outcomes of CT screening by assessing the number and stage of lung cancers detected by screening using Lung-RADS criteria |
| Economic Outcomes | Duration of the study, up to 3 years | Evaluate the costs associated with managing lung cancers detected by screening |
Countries
United States
Outcome results
None listed