Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors

Cancer Clinical Trial

— TILT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007274
• Other study ID #: CARDIO-04-2022
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2023
• Source: Institut Mutualiste Montsouris
• Contact: Isabelle Sauret, Mme
• Phone: +33156616705
• Email: isabelle.sauret[@]imm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Immune Checkpoint Inhibitor

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris	Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major cardiovascular event	Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death	5 years
Secondary	Completion of cancer therapy as scheduled	Cardiovascular contre indication to immune checkpoint inhibitors	5 years