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Recruiting NCT05898594

Lung Cancer Screening in High-risk Black Individuals

No phase Interventional Lung Cancer Lung Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose Computed Tomography.
Who it may be relevant to
Registry conditions: Lung Cancer, Lung Carcinoma. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Procedure Low-dose Computed Tomography
    Per standard care

Primary outcome measures

  • Proportion of Enrolled Participants [Time frame: At enrollment]
  • Proportion of Participants with Positive Low-dose Computed Tomography Test [Time frame: At 3 months]
  • Proportion of Participants Diagnosed with Invasive Lung Cancer [Time frame: At 6 months]
  • Distribution of Lung Imaging Reporting and Data System (Lung-RADS) Scores [Time frame: At 3 months]
Secondary outcome measures (2)
  • Proportion of Participants Who Undergo Invasive Diagnostic Procedures [Time frame: At 6 months]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 2 centers
  • University of Chicago — Chicago
  • Massachusetts General Hospital Cancer Center — Boston

Identifiers

NCT: NCT05898594 · 22-382 · 1R18HS029430-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗