Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomograph... | NCT04577599

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

NCT04577599

Sponsor

Wake Forest University Health Sciences

Status

Recruiting

Last Update Posted

Jan 21, 2026Actual

Enrollment

1,160Estimated

Phase

Not Applicable

Conditions

Lung Neoplasms
Lung Cancer

Interventions

Mobile Low-dose Computed Tomography (LDCT) Screening

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
00045190	Other Identifier	Advarra IRB
LCI-LUN-NOS-MoCT-002	Other Identifier	Atrium

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2021Actual

Primary Completion Date

Oct 2028Estimated

Completion Date

Oct 2028Estimated

First Submitted Date

Sep 30, 2020

First Submission Date that Met QC Criteria

Sep 30, 2020

First Posted Date

Oct 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2026

Last Update Posted Date

Jan 21, 2026Actual

Name	Class
Leon Levine Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Other	Mobile Low-dose Computed Tomography (LDCT) Screening	Other: Mobile Low-dose Computed Tomography (LDCT) Screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mobile Low-dose Computed Tomography (LDCT) Screening	Other	Low Dose CT Scan of the Chest	Single Arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

54 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Darcy Doege, RN	Contact	913-424-6431		Darcy.Doege@atriumhealth.org

Overall Officials

Name	Affiliation	Role
Daniel Carrizosa, MD	LCI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Levine Cancer Institute	Recruiting	Charlotte	North Carolina	28204	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D012907	Smoking

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008403	Mass Screening

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006306	Health Surveys
D011795	Surveys and Questionnaires

Browse Leaves

Not provided

Browse Branches

Not provided