Investigating cardiovascular effects of immune checkpoint inhibitors in cancer patients
Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside
This study is testing how immune checkpoint inhibitors used for cancer treatment might affect heart health in patients by looking at changes in blood flow and other markers before and after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Mutualiste Montsouris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06020651 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the mechanisms behind atherosclerotic plaque instability in patients receiving immune checkpoint inhibitors (ICIs) for various cancers. It will involve a prospective pilot approach, comparing surrogate markers of vascular toxicity and circulating biomarkers before and after ICI treatment. The study will utilize arterial Doppler measurements to assess flow-mediated reserve, a key indicator of endothelial function. By understanding these mechanisms, the research seeks to shed light on the cardiovascular risks associated with ICIs.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for their first ICI therapy and matched controls with cancer who are not receiving ICI treatment.
Not a fit: Patients with a major cardiovascular event in the past six months or those with a history of ICI therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of cardiovascular risks in cancer patients undergoing ICI therapy.
How similar studies have performed: While the specific mechanisms of atherosclerosis related to ICIs have not been extensively studied, there is growing interest in the cardiovascular effects of cancer therapies, indicating potential for novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients scheduled for first ICI therapy at our institution; * Matched controls with cancer and no ICI therapy; Exclusion Criteria: * Major cardiovascular event in the past 6 months; * Unable to provide informed consent; * History of ICI therapy
Where this trial is running
Paris
- INstitut Mutualiste Montsouris — Paris, France (Recruiting)
Study contacts
- Study coordinator: Isabelle Sauret, MBS
- Email: isabelle.sauret@imm.fr
- Phone: +33 1 56 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.