Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume

Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume in Patients With Non-Small Cell Lung Cancer: A Case-Control Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04430712

Enrollment

Registered

2020-06-12

Start date

2020-08-01

Completion date

2022-08-22

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer, Immune Checkpoint Inhibitor, Atherosclerosis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results