Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Ages 40-54
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-54
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Known diagnosis of lung cancer in the past 5 years.
Any known contraindication to having a low-dose CT Scan.
Known pregnancy.
Trial design
Design model
Single group
Treatments tested in this trial
Mobile Low-dose Computed Tomography (LDCT) Screening
Other interventionLow Dose CT Scan of the Chest
Treatment groups
1,160 Participants
are divided into 1 treatment groupGroup A: Single ArmOther 1 intervention
Trial outcomes
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.
Time frame
1 daySecondary outcomes
1
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.
Time frame
up to 24 months2
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.
Time frame
up to 24 months3
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.
Time frame
up to 24 months4
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.
Time frame
up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Leon Levine Foundation
Collaborator
Source ClinicalTrials.gov