Pilot Study of High Risk Lung Cancer Screening

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683940
• Other study ID #: 15-1694.cc
• Status: Completed
• Phase: N/A
• Start date: August 10, 2016
• Est. completion date: November 9, 2023

Study information

• Verified date: December 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 9, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 82 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• Screening
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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Cancer Screening	Prospectively identify patients for lung cancer screening using risk calculators	Duration of the study, up to 3 years
Primary	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
Primary	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
Primary	Economic Outcomes	Evaluate the costs associated with managing lung cancers detected by screening	Duration of the study, up to 3 years
Primary	Economic Outcomes	Evaluate the costs associated with managing the spectrum of other radiographic abnormalities	Duration of the study, up to 3 years