NCT04294771 JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors
| NCT ID | NCT04294771 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe Hospitalier Pitie-Salpetriere |
| Condition | Myocarditis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500,000 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500,000 participants in total. It began in 2019-01-01 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Immune checkpoint inhibitors (ICIs) might induce high grade immune-related adverse events (irAEs) involving the cardio-vascular system. This study investigates reports of cardio-vascular toxicity associated with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase, Assistance Publique Hopitaux de Paris Entrepot de Données de Santé (APHP.EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis
Eligibility Criteria
Inclusion Criteria: * Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2025 * Case reported in the APHP Entrepot de Données de Santé (EDS) database of individual safety case reports to 01/01/2025 * Case reported in the Système National Des Données de Santé (SNDS) Database of individual safety case reports to 01/01/2025 * Case reported in a retrospective international multicenter registry of ICI-associated myocarditis to 01/01/2025 * Adverse event reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT) * Patients treated with ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), Cemiplimab (L01XC33) Exclusion Criteria: * Chronology not compatible between the drug and the toxicity
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04294771 clinical trial?
This trial is open to participants of all sexes, studying Myocarditis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04294771 currently recruiting?
Yes, NCT04294771 is actively recruiting participants. Contact the research team at joe-elie.salem@aphp.fr for enrollment information.
Where is the NCT04294771 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04294771 clinical trial?
NCT04294771 is sponsored by Groupe Hospitalier Pitie-Salpetriere. The trial plans to enroll 500,000 participants.