Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2022
CompletedAugust 25, 2022
August 1, 2022
2 years
June 10, 2020
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in aortic plaque volume
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.
Three years
Eligibility Criteria
Patients with non-small cell lung cancer from a single tertiary care center in the United States.
You may qualify if:
- 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.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- AstraZenecacollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Drobni ZD, Gongora C, Taron J, Suero-Abreu GA, Karady J, Gilman HK, Supraja S, Nikolaidou S, Leeper N, Merkely B, Maurovich-Horvat P, Foldyna B, Neilan TG. Impact of immune checkpoint inhibitors on atherosclerosis progression in patients with lung cancer. J Immunother Cancer. 2023 Jul;11(7):e007307. doi: 10.1136/jitc-2023-007307.
PMID: 37433718DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 12, 2020
Study Start
August 1, 2020
Primary Completion
August 12, 2022
Study Completion
August 22, 2022
Last Updated
August 25, 2022
Record last verified: 2022-08