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Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside

NCT06020651 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-31

No results posted yet for this study

Summary

Immune checkpoint inhibitors (ICIs) are largely prescribed in a growing number of cancer diseases and at earlier stages (non metastatic cancer). Among immune-related adverse events, (iRAEs), the incidence of major cardiovascular events due to atherosclerosis reaches 13% at one year in patients at high risk. To the best of our knowledge, the mechanisms of this acceleration of atherosclerosis have not been studied to this date.

The VICKI study aims at furthering our knowledge on the mechanisms of atherosclerotic plaque instability by means of a prospective single-centre pilot study, by comparing:

* surrogate markers of clinical vasculo-toxicity with arterial Doppler (flow mediated reserve) as defined by the International Cardio-Oncology Society;
* circulating biomarkers

Before and after receiving ICIs for solid cancer treatment.

Conditions

  • Renal Cell Carcinoma
  • Bladder Cancer
  • MSI-H Cancer
  • Cancer

Interventions

DIAGNOSTIC_TEST

Arterial Doppler for Flow Mediated Reserve measurement

Arterial Doppler (ultrasound, no radiation, no contrast agent) and blood sampling twice for participants on ICIs

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Institut Mutualiste Montsouris

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2024-12-30
Completion
2025-06-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06020651 on ClinicalTrials.gov