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NCT Number: NCT04577599

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

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.

Recruiting

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Key information

Age range

40 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location status: Recruiting

Location contact

Daniel Carrizosa, MD

PRINCIPAL_INVESTIGATOR

Darcy Doege, RN

CONTACT

[email protected]

913-424-6431

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile Low-dose Computed Tomography (LDCT) Screening

Other

Low Dose CT Scan of the Chest

Primary outcomes

  1. 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.

Secondary outcomes

  1. Lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2)

    Time frame: up to 24 months

    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.

  2. Positive screening rate at T0, T1, and T2

    Time frame: up to 24 months

    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.

  3. 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

    All binary outcomes will be analyzed using logistic regression models to evaluate the impact of baseline demographic, socioeconomic, and health care-related factors.

  4. Incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening

    Time frame: up to 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Darcy Doege, RN

CONTACT

[email protected]

913-424-6431

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Leon Levine Foundation

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Oct 8, 2020
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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