Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors (TILT)

Institut Mutualiste Montsouris

Status: Completed

Conditions: Cardiovascular Biomarkers; Immune Checkpoint Inhibitor; Cancer

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06007274

CARDIO-04-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

300 participants in 2 patient groups

Active surveillance by means of troponin measurements

Treatment:

Other: No intervention

No active surveillance by means of troponin measurements