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NCT04430712 · ClinicalTrials.gov registry record
Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 60
- Enrollment target
NCT04430712: Completed study, sponsored by Massachusetts General Hospital.
NCT04430712 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04430712 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
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 Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2022-08-22 |
What the finished NCT04430712 record still lists
NCT04430712 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04430712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04430712 about?
NCT04430712 is a clinical study titled "Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume". 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 criti...
What is the current status of trial NCT04430712?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2020-08-01. Estimated completion is 2022-08-22.
Who is sponsoring clinical trial NCT04430712?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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