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Completed

NCT Number: NCT06007274

Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors

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.

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Key information

Conditions

Cancer Cardiovascular Biomarkers Immune Checkpoint Inhibitor Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Mutualiste Montsouris

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Major cardiovascular event

    Time frame: 5 years

    Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death

Secondary outcomes

  1. Completion of cancer therapy as scheduled

    Time frame: 5 years

    Cardiovascular contre indication to immune checkpoint inhibitors

Sponsors and collaborators

Lead sponsor

Institut Mutualiste Montsouris

Other

Collaborators

  • Institut Curie

Registry information

Official study title

Troponin to Detect Major Cardiovasculaire Advserse Events on Immune: a Case Control Retrospective Study

Acronym: TILT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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