Genetic Determinants of Myocarditis Induced by Immune-checkpoint Inhibitors
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 23 Sept 2025
- Expected to end
- 20 Jul 2028
- Type of study
- Observational, 3 groups
- Record updated
- 21 November 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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)
- Signature of informed consent before any trial procedure from the patient
- Patients covered by social security regimen (excepting AME)
Who cannot take part
- 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)
- Age <18 years of age
- Pregnant or breast-feeding women
- 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.)
Where in France
- Hopital Pitie-SalpetriereParis, FranceContact: Joe Elie SALEM, PrTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- ICI-tolerant patients without suspicion of myotoxicity (Controls)
300 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 new cardio-muscular symptoms or ECG abnormality or wall motion abnormality or troponin-T increase (above Upper Limit of Normal if normal prior to ICI start, or over twice its troponin-T baseline value if abnormal before ICI start)
- Patients with refuted suspicion of ICI-myocarditis (controls)
100 Cancer patients treated with ICI and with definite ICI-induced myocarditis according to last updated diagnostic criteria's
- ICI-Myocarditis Cases (Cases)
100 Cancer patients treated with ICI admitted for a suspicion of ICI-myocarditis subsequently infirmed
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 21 November 2025