Lung NeoplasmsNCT04577599
Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Ages 40-54
A study testing Mobile Low-dose Computed Tomography (LDCT) Screening in people with Lung Neoplasms and Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasms, Lung Cancer
- What is being tested?
- Mobile Low-dose Computed Tomography (LDCT) Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must meet all the following applicable inclusion criteria to participate in this study:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Darcy Doege, RN, 913-424-6431, Darcy.Doege@atriumhealth.org
Daniel Carrizosa, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Mobile Low-dose Computed Tomography (LDCT) Screening
- Keywords
- Screening, Lung Cancer, Smoking
- Medical subject headings
- Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Low-dose Computed Tomography (LDCT) ScreeningOther
Low Dose CT Scan of the Chest
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Mobile Low-dose Computed Tomography (LDCT) Screening Receives: Other: Mobile Low-dose Computed Tomography (LDCT) Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start7 Jan 2021
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Leon Levine Foundation
- Responsible party
- Sponsor
- Investigators
- Daniel Carrizosa, MD, Principal investigator, LCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577599
- Sponsor's protocol ID
- IRB00081444
- Other IDs
- 00045190, LCI-LUN-NOS-MoCT-002
- Status last verified
- Jul 2026
- First submitted
- 30 Sep 2020
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04577599
- Acronym / sponsor ID
- IRB00081444
- Conditions
- Lung Neoplasms, Lung Cancer
- Keywords
- Screening, Lung Cancer, Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Leon Levine Foundation
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Other: Mobile Low-dose Computed Tomography (LDCT) ScreeningMobile Low-dose Computed Tomography (LDCT) Screening |
Who may qualify
- Ages
- 40 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject must meet all the following applicable inclusion criteria to participate in this study:
Key exclusion criteria (4 listed)
- Subjects meeting any of the criteria below may not participate in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Low-dose Computed Tomography (LDCT) ScreeningLow Dose CT Scan of the Chest | Other | Single Arm |
Primary outcome
Lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT.
Time frame: 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.
4 secondary outcomes
Lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2)
Time frame: up to 24 months
Positive screening rate at T0, T1, and T2
Time frame: up to 24 months
Impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates
Time frame: up to 24 months
Incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Carrizosa, MD principal investigator
LCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Low-dose Computed Tomography (LDCT) Screening in people with Lung Neoplasms and Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darcy Doege, RN (913-424-6431, Darcy.Doege@atriumhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.