Lung Cancer Screening in High-risk Black Women

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898594
• Other study ID #: 22-382
• Secondary ID: 1R18HS029430-01
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Chi Fu Jeffrey Yang, MD
• Phone: 617-724-1681
• Email: cjyang[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research study is to study U.S. Black women 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

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 women with a history of smoking.

LDCT screening is currently the only recommended way to screen for lung cancer among high-risk individuals. However, the majority of Black women 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-identified Black women.

• 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 women 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. Women 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Carcinoma
• Lung Neoplasms

Intervention

Procedure:
• Low-dose Computed Tomography
Per standard care

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Enrolled Participants	Primary endpoint is feasibility. Feasibility is defined as the percentage of invited participants of the Black Women's Health Study (BWHS) who enroll.	At enrollment
Primary	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 women randomized to the low-dose computed tomography screening arm in the National Lung Screening Trial (historical control).	At 3 months
Primary	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 women randomized to the LDCT screening arm in the National Lung Screening Trial (historical control).	At 6 months
Primary	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 women randomized to the LDCT screening arm in the National Lung Screening Trial (historical control).	At 3 months
Secondary	Proportion of Participants Who Undergo Invasive Diagnostic Procedures	The proportion of participants who undergo invasive diagnostic procedures will be evaluated and compared to the proportion of Black women randomized to the LDCT screening arm in the National Lung Screening Trial (historical control) who underwent invasive diagnostic procedures.	At 6 months
Secondary	Proportion of Participants Who Have a Complication Resulting from an Invasive Diagnostic Procedure Performed for a Positive Low-dose Computed Tomography Scan	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 women 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.	At 6 months