Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors

NCT ID: NCT06007274

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-07-01

Brief Summary

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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

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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.

Conditions

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Cancer Immune Checkpoint Inhibitor Cardiovascular Biomarkers

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Active surveillance by means of troponin measurements

No intervention

Intervention Type OTHER

No intervention

No active surveillance by means of troponin measurements

No interventions assigned to this group

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role collaborator

Institut Mutualiste Montsouris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariana Mirabel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Mutualiste Montsouris

Locations

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Institut Mutualiste Montsouris

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CARDIO-04-2022

Identifier Type: -

Identifier Source: org_study_id

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