Recruiting

LDCT

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04577599

Conditions

Lung Neoplasms

Lung Cancer

Eligibility Criteria

Sex: All

Age: 40 - 54

Healthy Volunteers: Accepted

Interventions

Mobile Low-dose Computed Tomography (LDCT) Screening

Study Details

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.

Conditions

Lung Neoplasms

Lung Cancer

Study ID

NCT04577599

Start date

Jan 7, 2021

Status verified date

Jul, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 54

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Single Arm

Mobile Low-dose Computed Tomography (LDCT) Screening

Interventions

Mobile Low-dose Computed Tomography (LDCT) Screening

Low Dose CT Scan of the Chest

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Darcy Doege, RN

913-424-6431Darcy.Doege@atriumhealth.org

Locations

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Darcy Doege, RN

913-424-6431Darcy.Doege@atriumhealth.org

Principal Investigator:

Daniel Carrizosa, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Screening
  • Lung Cancer
  • Smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-13.