Pilot Study of High Risk Lung Cancer Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Pilot Study of Lung Cancer Screening in Patients at High Risk for Lung Cancer Who Do Not Meet Current Screening Guidelines

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Screening


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Screening<br>Subjects will undergo a low dose non contrast CT chest for lung cancer screening. | Diagnostic Test: Screening<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Cancer Screening | Prospectively identify patients for lung cancer screening using risk calculators | Duration of the study, up to 3 years | 
| Medical Outcomes | Evaluate health outcomes of CT screening by assessing the number and stage of lung cancers detected by screening using Lung-RADS criteria | Duration of the study, up to 3 years | 
| Medical Outcomes | Evaluate health outcomes of CT screening by assessing the number and stage the spectrum of other radiographic abnormalities detected using Lung-RADS criteria | Duration of the study, up to 3 years | 
| Economic Outcomes | Evaluate the costs associated with managing lung cancers detected by screening | Duration of the study, up to 3 years | 
| Economic Outcomes | Evaluate the costs associated with managing the spectrum of other radiographic abnormalities | Duration of the study, up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilot Study, High Risk, Prospective, Screening