Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume

Mass General Brigham

Status: Completed

Conditions: Non-small Cell Lung Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04430712

2020P000361

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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