Pilot Study of High Risk Lung Cancer Screening

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Screening

• Registration Number: NCT03683940
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2016-08-10
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Primary Completion: 2023-04-25
• Study Completion: 2023-11-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening	Screening	Subjects will undergo a low dose non contrast CT chest for lung cancer screening.

Primary Outcome Measures

Name	Time	Method
Economic Outcomes	Duration of the study, up to 3 years	Evaluate the costs associated with managing the spectrum of other radiographic abnormalities
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 the spectrum of other radiographic abnormalities detected using Lung-RADS criteria

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Denver, Colorado, United States