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Trial Title:
Lung Cancer Screening in High-risk Black Women
NCT ID:
NCT05898594
Condition:
Lung Cancer
Lung Carcinoma
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung Cancer
Lung Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Low-dose Computed Tomography
Description:
Per standard care
Arm group label:
Screening: Low-Dose Computed Tomography Screening
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chi Fu Jeffrey Yang, MD
Phone:
617-724-1681
Email:
cjyang@mgh.harvard.edu
Start date:
September 6, 2023
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
Agency for Healthcare Research and Quality (AHRQ)
Agency class:
U.S. Fed
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05898594
