NCT04577599

Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Ages 40-54

Lung B.A.S.E.S 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Assessing Incidence and Stage of Lung Cancer Diagnosis in Subjects Ages 40-54 With a 30 Pack Year History or More Within North and South Carolina

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,160 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 54 Years
• Healthy volunteers: Accepted

Summary

Low-dose CT Screening has been shown in two large trials in the United States (NLST) and Europe (NELSON) to increase overall survival in subjects 55 years of age and older with a strong smoking history. Unfortunately, in both North Carolina (NC) and South Carolina (SC), subjects are found to have the above referenced smoking history prior to reaching the minimum age in these studies. This study is aimed at decreasing the minimum age of screening in a high-risk population.

Detailed description

The primary objective of this study is to evaluate the lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT. Secondary objectives include evaluating the lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2); evaluating the positive screening rate at T0, T1, and T2; evaluating the impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates; and summarizing the incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening. Enrollment will continue until 174 subjects are identified in the evaluable population with a total of 1160 subjects anticipated to be enrolled and screened.

Conditions

• Lung Neoplasms
• Lung Cancer

Interventions

Type	Name	Description
OTHER	Mobile Low-dose Computed Tomography (LDCT) Screening	Low Dose CT Scan of the Chest

Timeline

• Start date: 2021-01-07
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2020-10-08
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States