Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors

Completed

• Conditions: Cardiovascular Biomarkers; Cancer; Immune Checkpoint Inhibitor
• Interventions: Other: No intervention

• Registration Number: NCT06007274
• Lead Sponsor: Institut Mutualiste Montsouris

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.

Study Timeline

• Study First Submitted: 2023-05-10
• Study Start: 2023-07-01
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-23
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active surveillance by means of troponin measurements	No intervention	-

Primary Outcome Measures

Name	Time	Method
Major cardiovascular event	5 years	Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death

Secondary Outcome Measures

Name	Time	Method
Completion of cancer therapy as scheduled	5 years	Cardiovascular contre indication to immune checkpoint inhibitors

Trial Locations

Locations (1)

Institut Mutualiste Montsouris; 🇫🇷 Paris, France