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

Not Applicable

Recruiting

• Conditions: Lung Neoplasms; Lung Cancer
• Interventions: Other: Mobile Low-dose Computed Tomography (LDCT) Screening

• Registration Number: NCT04577599
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-08
• Study Start: 2021-01-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1160

Inclusion Criteria

• Subject must meet all the following applicable inclusion criteria to participate in this study:

  1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  2. Age 40-54 years at the time of consent.
  3. A positive smoking history of greater/equal to 30 pack years and they are either currently smoking or have quit within the last 15 years.
  4. Ability to read and understand the English and/or Spanish language.
  5. Ability to understand and comply with study procedures for the entire length of the study.

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Exclusion Criteria

• Subjects meeting any of the criteria below may not participate in the study:

  1. Known diagnosis of lung cancer in the past 5 years.
  2. Any known contraindication to having a low-dose CT Scan.
  3. Known pregnancy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Mobile Low-dose Computed Tomography (LDCT) Screening	Mobile Low-dose Computed Tomography (LDCT) Screening

Primary Outcome Measures

Name	Time	Method
Lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT.	1 day	The lung cancer diagnosis variable will be determined for each subject as a binary variable indicating whether or not the subject's T0 screening results in a diagnosis of lung cancer.

Secondary Outcome Measures

Name	Time	Method
Positive screening rate at T0, T1, and T2	up to 24 months	The positive screening variable at T0, T1 and at T2 will be determined for each subject as a binary variable indicating whether or not the subject's screening results indicate a Lung RADS of 3 or 4.
Impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates	up to 24 months	All binary outcomes will be analyzed using logistic regression models to evaluate the impact of baseline demographic, socioeconomic, and health care-related factors.
Incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening	up to 24 months	Incidental cancer diagnosis resulting from LDCT scan findings at T0, at T1, and at T2 will be captured for each subject including binary value of yes vs no for other cancer diagnosis, diagnosis date, type of cancer, and stage of disease.
Lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2)	up to 24 months	The lung cancer diagnosis variable will be determined for each subject as a binary variable indicating whether or not the subject's T1 and T2 screening results in a diagnosis of lung cancer.

Trial Locations

Locations (1)

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States