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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasms; Lung Cancer
• Intervention / Treatment: Other: Mobile Low-dose Computed Tomography (LDCT) Screening

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.

• Study Type: Interventional
• Enrollment (Estimated): 1160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Darcy Doege, RN; Phone Number: 913-424-6431; Email: Darcy.Doege@atriumhealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Institute
      • Contact: Darcy Doege, RN; Phone Number: 913-424-6431; Email: Darcy.Doege@atriumhealth.org
      • Principal Investigator: Daniel Carrizosa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 54 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; Mobile Low-dose Computed Tomography (LDCT) Screening	Other: Mobile Low-dose Computed Tomography (LDCT) Screening; Low Dose CT Scan of the Chest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT.	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2)	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.	up to 24 months
Positive screening rate at T0, T1, and T2	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.	up to 24 months
Impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates	All binary outcomes will be analyzed using logistic regression models to evaluate the impact of baseline demographic, socioeconomic, and health care-related factors.	up to 24 months
Incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening	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.	up to 24 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Leon Levine Foundation
• Investigators: Principal Investigator: Daniel Carrizosa, MD, LCI

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer; Smoking; Screening
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: IRB00081444; 00045190 (Other Identifier: Advarra IRB); LCI-LUN-NOS-MoCT-002 (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No