Clinical trial · Interventional
Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| MSI-H Cancer | — | UNRESOLVED | — |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arterial Doppler for Flow Mediated Reserve measurement | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- ICIs alone
- description
- Participants on ICIs alone
- interventionNames
- Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement
- type
- EXPERIMENTAL
- label
- ICIs + VEGF inhibitors
- description
- Participants on ICIs + VEGF inhibitors
- interventionNames
- Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement
- type
- EXPERIMENTAL
- label
- ICIs + chemotherapy
- description
- Participants on ICIs + chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available