Clinical trial NCT04577599: Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Ages 40-54
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Neoplasms
Lung Cancer
Keywords: Screening
Lung Cancer
Smoking
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Leon Levine Foundation
First posted: 2020-10-08
Enrollment: 1160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT.
timeFrame: 1 day
Secondary outcomes:
measure: Lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2)
timeFrame: up to 24 months
measure: Positive screening rate at T0, T1, and T2
timeFrame: up to 24 months
measure: Impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates
timeFrame: up to 24 months
measure: Incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: LCI
name: Daniel Carrizosa, MD
role: PRINCIPAL_INVESTIGATOR
References: