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

NCT04577599 | Recruiting DMC

• 3 other identifiers: IRB0008144400045190LCI-LUN-NOS-MoCT-002
• Study Type: interventional
• Target: 1,160
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Lung Cancer

Keywords

Screening; Lung Cancer; Smoking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2)

  up to 24 months

• Positive screening rate at T0, T1, and T2

  up to 24 months

• Impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates

  up to 24 months

• Incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening

  up to 24 months

Study Arms (1)

Single Arm

OTHER

Mobile Low-dose Computed Tomography (LDCT) Screening

Other: Mobile Low-dose Computed Tomography (LDCT) Screening

Interventions

Mobile Low-dose Computed Tomography (LDCT) Screening OTHER

Low Dose CT Scan of the Chest

Single Arm

Eligibility Criteria

• Age: 40 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Age 40-54 years at the time of consent.
• 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.
• Ability to read and understand the English and/or Spanish language.
• Ability to understand and comply with study procedures for the entire length of the study.

You may not qualify if:

• Subjects meeting any of the criteria below may not participate in the study:
• Known diagnosis of lung cancer in the past 5 years.
• Any known contraindication to having a low-dose CT Scan.
• Known pregnancy.

Sponsors & Collaborators

• Leon Levine Foundation: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Smoking

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Daniel Carrizosa, MD

  LCI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darcy Doege, RN

CONTACT

913-424-6431; Darcy.Doege@atriumhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 8, 2020
• Study Start: January 7, 2021
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)