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

Primary Purpose

Lung Neoplasms, Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Low-dose Computed Tomography (LDCT) Screening
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Neoplasms

Eligibility Criteria

40 Years - 54 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Levine Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

Mobile Low-dose Computed Tomography (LDCT) Screening

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 30, 2020
Last Updated
July 23, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Leon Levine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04577599
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Leon Levine Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Lung Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
Mobile Low-dose Computed Tomography (LDCT) Screening
Intervention Type
Other
Intervention Name(s)
Mobile Low-dose Computed Tomography (LDCT) Screening
Intervention Description
Low Dose CT Scan of the Chest
Primary Outcome Measure Information:
Title
Lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT.
Description
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 day
Secondary Outcome Measure Information:
Title
Lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2)
Description
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 months
Title
Positive screening rate at T0, T1, and T2
Description
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 months
Title
Impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates
Description
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 months
Title
Incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening
Description
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 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darcy Doege, RN
Phone
913-424-6431
Email
Darcy.Doege@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Carrizosa, MD
Organizational Affiliation
LCI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darcy Doege, RN
Phone
913-424-6431
Email
Darcy.Doege@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Carrizosa, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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