Lung Cancer Screening in High-risk Black Individuals

NCT ID: NCT05898594

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-06

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening: Low-Dose Computed Tomography Screening

Participants 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.

Group Type EXPERIMENTAL

Low-dose Computed Tomography

Intervention Type PROCEDURE

Per standard care

Interventions

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Low-dose Computed Tomography

Per standard care

Intervention Type PROCEDURE

Eligibility Criteria

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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 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chi-Fu Jeffrey Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chi Fu Jeffrey Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chi Fu Jeffrey Yang, MD

Role: CONTACT

617-724-1681

Facility Contacts

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Jessica Donington, MD

Role: primary

773-834-6121

Chi Fu Jeffrey Yang, MD

Role: primary

617-724-1681

Other Identifiers

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1R18HS029430-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

22-382

Identifier Type: -

Identifier Source: org_study_id

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