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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18HS029430-01 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening: Low-Dose Computed Tomography Screening | Experimental | Participants will undergo study procedures as outlined:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose Computed Tomography | Procedure | Per standard care |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control) who underwent invasive diagnostic procedures. | At 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi Fu Jeffrey Yang, MD | Contact | 617-724-1681 | cjyang@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chi Fu Jeffrey Yang, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 individuals 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 |
| Massachusetts General Hospital Cancer Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |