NCT06734689 Genetic Determinants of Myocarditis Induced by Immune-checkpoint Inhibitors
| NCT ID | NCT06734689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | ICI-myocarditis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2028-01-20 |
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 participants in total. It began in 2025-09-23 with a primary completion date of 2028-01-20.
⚠ 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 (ICI) are active in multiple cancers. Their main drawback is the incidence of immune related adverse events; among which ICI-myocarditis (ICIM) is rare but can be the most life-threatening (up to 50% lethal). ICIM is due to ICI unleashing cytotoxic auto-reactive T-cells recognizing a culprit target antigen located on muscles and destroying them. Most often, ICIM occurs within a systemic ICI-myotoxicity, with peripheral muscular involvement (ICI-myositis), mimicking eventually myasthenia-gravis syndrome. Human Leukocyte Antigen (HLA) are cell surface proteins key for the regulation of the immune system acting via presentation of culprit antigens by antigen presenting cells (macrophages) to T-cells, subsequently triggering the destruction/tolerance of cells carrying this antigen. The HLA system (chromosome 6) is the most polymorphic region in the human genome and is associated with auto-immunity including myocarditis. HLA class I alleles have been strongly associated with some T-cell-mediated drug hypersensitivity reactions with handful patients needed to be tested to prevent a single case, leading to globally required cost-effective HLA typing pre-prescription for some drugs.
Eligibility Criteria
Inclusion Criteria: 1. Cancer patients on ICI since at least 3 months with a minimum of 2 ICI doses received having no appearance (as compared to baseline known pre-ICI) of a new cardio-muscular symptoms or ECG abnormality or WMA or troponin-T increase (above ULN if normal prior to ICI start, or over twice its troponin-T baseline value if abnormal before ICI start). 2. Signature of informed consent before any trial procedure from the patient 3. Patients covered by social security regimen (excepting AME). Exclusion Criteria: 1. Age \<18 years of age. 2. Pregnant or breast-feeding women 3. People under legal protection measure (safeguard measures) Specific exclusion criteria for the magnetic resonance imaging sub-study (MRI) * Patients with a contraindication to MRI (claustrophobia, some wearing equipment with magnetic properties: pacemaker, ferromagnetic equipment, etc.) * Intolerance to gadolinium, or severe renal insufficiency (GFR\<30 ml/min/1.73 m2). Of note, the other groups of patients needed to complete this study; i.e the patients with refuted suspicion of ICI-myocarditis who will serve as controls, and the patients with ICI-myocarditis (cases) are included in another protocol (NCT05454527)
Contact & Investigator
Joe Elie SALEM, Pr
PRINCIPAL INVESTIGATOR
Assitance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06734689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ICI-myocarditis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06734689 currently recruiting?
Yes, NCT06734689 is actively recruiting participants. Contact the research team at joe-elie.salem@aphp.fr for enrollment information.
Where is the NCT06734689 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06734689 clinical trial?
NCT06734689 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Joe Elie SALEM, Pr at Assitance Publique - Hôpitaux de Paris. The trial plans to enroll 500 participants.