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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2028-10-31

Brief Summary

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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.

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Detailed Description

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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

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Lung Neoplasms Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Single Arm

Mobile Low-dose Computed Tomography (LDCT) Screening

Group Type OTHER

Mobile Low-dose Computed Tomography (LDCT) Screening

Intervention Type OTHER

Low Dose CT Scan of the Chest

Interventions

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Mobile Low-dose Computed Tomography (LDCT) Screening

Low Dose CT Scan of the Chest

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes