Back to resultsLung Cancer Screening in High-risk Black Women
Primary Purpose
Lung Cancer, Lung Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-dose Computed Tomography
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer focused on measuring Lung Cancer, Lung Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Massachusetts General Hospital Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Screening: Low-Dose Computed Tomography Screening
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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).
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).
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05898594
First Posted
May 26, 2023
Last Updated
October 5, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT05898594
Brief Title
Lung Cancer Screening in High-risk Black Women
Official Title
Evaluating the Feasibility of Lung Cancer Screening in High-risk Black Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Carcinoma
Keywords
Lung Cancer, Lung Carcinoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Screening: Low-Dose Computed Tomography Screening
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low-dose Computed Tomography
Intervention Description
Per standard care
Primary Outcome Measure Information:
Title
Proportion of Enrolled Participants
Description
Primary endpoint is feasibility. Feasibility is defined as the percentage of invited participants of the Black Women's Health Study (BWHS) who enroll.
Time Frame
At enrollment
Title
Proportion of Participants with Positive Low-dose Computed Tomography Test
Description
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).
Time Frame
At 3 months
Title
Proportion of Participants Diagnosed with Invasive Lung Cancer
Description
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).
Time Frame
At 6 months
Title
Distribution of Lung Imaging Reporting and Data System (Lung-RADS) Scores
Description
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).
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Proportion of Participants Who Undergo Invasive Diagnostic Procedures
Description
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.
Time Frame
At 6 months
Title
Proportion of Participants Who Have a Complication Resulting from an Invasive Diagnostic Procedure Performed for a Positive Low-dose Computed Tomography Scan
Description
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.
Time Frame
At 6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Fu Jeffrey Yang, MD
Phone
617-724-1681
Email
cjyang@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Fu Jeffrey Yang, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Fu Jeffrey Yang, MD
Phone
617-724-1681
Email
cjyang@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation
Learn more about this trial
Lung Cancer Screening in High-risk Black Women
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