Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume

NCT ID: NCT04430712

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-08-22

Brief Summary

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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

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tomas G. Neilan, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37433718 (View on PubMed)

Other Identifiers

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2020P000361

Identifier Type: -

Identifier Source: org_study_id

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