Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT04430712
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment leads to an accelerated progression of atherosclerosis in patients with lung cancer. Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being targeted for cancer are critical negative regulators of atherosclerosis in animal and cellular models. Aortic plaque progression will be compared between cases (on ICI) and controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will be matched for age, cancer type and stage and cardiovascular risk factors. Traditional markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination therapy, number of cycles, occurrence of immune-related adverse events, chest radiation, steroid use) will be associated with the change in aortic plaque volume.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Study Start: 2020-08-01
• Status Verified: 2022-08
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-22
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Cases:

• Subjects with non-small cell lung cancer treated with Immune Checkpoint Inhibitors.
• Available contrast enhanced CT scans of the chest both immediately pre-ICI (< 1 month) and latest follow-up.

Controls:

• Subjects with non-small cell lung cancer, age, cancer stage and cardiovascular risk factor matched to cases.
• Available contrast enhanced CT scan of the chest at two time-points at a similar interval between scans as the cases.

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in aortic plaque volume	Three years	The change of plaque burden after starting ICIs will be calculated and compared with the pre-ICI study. The change in plaque burden in controls will be calculated and compared from two studies at a similar median interval as ICI cases.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States