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NCT Number: NCT05898594

Lung Cancer Screening in High-risk Black Individuals

The goal of this research study is to study U.S. Black individuals with a history of smoking to examine the feasibility, acceptability, and performance of low-dose computed tomography (LDCT) screening among this population.

The name of the intervention used in this research study is:

Low-dose computed tomography (radiologic scan) chest scan

Recruiting

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

The goal of this single-arm pilot research study is to evaluate the feasibility and acceptability of low-dose computed tomography (LDCT) screening for lung cancer among U.S. Black individuals with a history of smoking.

LDCT screening is currently the only recommended way to screen for lung cancer among high-risk individuals. However, many Black individuals at high-risk for lunch cancer are currently ineligible for lung cancer screening.

Study procedures include screening for eligibility, completion of questionnaires, and a LDCT screening test.

Participation in this study is expected to last up to 3 months.

It is expected about 900 people will participate in this study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Self-identified Black individual.
  • Have a self-reported history of smoking. No restriction will be placed on the number of smoking pack years participants must have nor the number of years former smokers must have quit smoking.
  • Aged 50-80 years.

Exclusion criteria

  • Individuals with a history of lung cancer.
  • Individuals with symptoms suggestive of lung cancer. We will evaluate whether individuals have symptoms suggestive of lung cancer by administering an online screening questionnaire, which will ask whether they have experienced shortness of breath, whether they become easily winded, and whether they have had a chronic cough within the last 12 weeks that has not improved. Individuals who select that they have any one of these symptoms will be advised to follow up with their primary doctor and will not be eligible to participate in the study.
  • Individuals with pneumonia or acute respiratory infection within 12 weeks prior to enrollment that was treated with antibiotics.

Treatment and study plan

Low-dose Computed Tomography

Procedure

Per standard care

Primary outcomes

  1. Proportion of Enrolled Participants

    Time frame: At enrollment

    Primary endpoint is feasibility. Feasibility is defined as the percentage of individuals invited to participate in the trial who enroll.

  2. Proportion of Participants with Positive Low-dose Computed Tomography Test

    Time frame: At 3 months

    The percentage of participants who have a positive low-dose computed tomography test will be evaluated. This percentage will be compared to the Black individuals randomized to the low-dose computed tomography screening arm in the National Lung Screening Trial (historical control).

  3. Proportion of Participants Diagnosed with Invasive Lung Cancer

    Time frame: At 6 months

    The proportion of participants with a lung cancer diagnosis post-low-dose computed tomography screening test will be compared to Black individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control).

  4. Distribution of Lung Imaging Reporting and Data System (Lung-RADS) Scores

    Time frame: At 3 months

    The distribution of Lung-RADS scores among participants will be evaluated and compared to the distribution of Lung-RADS scores among Black individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control).

Secondary outcomes

  1. Proportion of Participants Who Undergo Invasive Diagnostic Procedures

    Time frame: At 6 months

    The proportion of participants who undergo invasive diagnostic procedures will be evaluated and compared to the proportion of Black individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control) who underwent invasive diagnostic procedures.

  2. Proportion of Participants Who Have a Complication Resulting from an Invasive Diagnostic Procedure Performed for a Positive Low-dose Computed Tomography Scan

    Time frame: At 6 months

    The proportion of participants who have a complication resulting from an invasive diagnostic procedure performed for a positive low-dose computed tomography scan will be evaluated. This proportion will be compared to the proportion of Black individuals randomized to the low-dose computed tomography screening arm in the National Lung Screening Trial (historical control) who had a complication resulting from an invasive diagnostic procedure performed for a positive low-dose computed tomography scan.

Study contacts

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

Chi Fu Jeffrey Yang, MD

CONTACT

[email protected]

617-724-1681

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Evaluating the Feasibility of Lung Cancer Screening in High-risk Black Individuals

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2023
Registry last updated
Feb 23, 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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