Cancer, Cardiovascular Biomarkers, Immune Checkpoint Inhibitor
Conditions
Brief summary
Recent guidelines suggest the use of troponin to detect immnune related cardiovascular advserse events in patients treated by immune checkpoint inhibitors for cancer. However, there is no proof that patients on immune checkpoint inhibitors benefit from this active surveillance strategy. The suspicion of cardiovascular events may lead to the interruption of cancer therapies. The TILT study aims at assessing: (i) the efficiency of troponin measurments in asymptomatic patients to prevent the further advent of major cardiovascular events; (ii) its safety in terms of cancer therapy completion.
Detailed description
Retrospective two-center study comparing two groups of patients on immune checkpoint inhibitors: * Group 1: active surveillance by serial troponin measures not prompted by cardiovascular symptoms ; * Group 2: no troponin measures. For any solid cancer or stage.
Interventions
OTHERNo intervention
No intervention
Sponsors
Institut Mutualiste Montsouris
Institut Curie
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All solid cancer patients treated by immune checkpoint inhibitors 2017-2022
Exclusion criteria
* Patients enrolled in an invterventional study (e.g., pharma trial)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiovascular event | 5 years | Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of cancer therapy as scheduled | 5 years | Cardiovascular contre indication to immune checkpoint inhibitors |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMariana Mirabel, MD, PhD
Institut Mutualiste Montsouris
Outcome results
None listed