Lung Cancer Screening in High-risk Black Individuals
Evaluating the Feasibility of Lung Cancer Screening in High-risk Black Individuals
2 other identifiers
interventional
900
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Sep 2023
Longer than P75 for not_applicable lung-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedStudy Start
First participant enrolled
September 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
February 23, 2026
February 1, 2026
4.8 years
May 26, 2023
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Proportion of Enrolled Participants
Primary endpoint is feasibility. Feasibility is defined as the percentage of individuals invited to participate in the trial who enroll.
At enrollment
Proportion of Participants with Positive Low-dose Computed Tomography Test
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).
At 3 months
Proportion of Participants Diagnosed with Invasive Lung Cancer
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).
At 6 months
Distribution of Lung Imaging Reporting and Data System (Lung-RADS) Scores
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).
At 3 months
Secondary Outcomes (2)
Proportion of Participants Who Undergo Invasive Diagnostic Procedures
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
At 6 months
Study Arms (1)
Screening: Low-Dose Computed Tomography Screening
EXPERIMENTALParticipants will undergo study procedures as outlined: * Complete questionnaires pre- and post- low-dose computed tomography (LDCT) test. * Visit Massachusetts General Hospital facility for a LDCT screening test.
Interventions
Per standard care
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Chicago
Chicago, Illinois, 60637, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chi Fu Jeffrey Yang, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 26, 2023
First Posted
June 12, 2023
Study Start
September 6, 2023
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.