Troponin to Detect Major Cardiovasculaire Advserse Events... | NCT06007274

Studies
Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors

NCT06007274

Sponsor

Institut Mutualiste Montsouris

Status

Completed

Last Update Posted

Apr 8, 2026Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Cancer
Immune Checkpoint Inhibitor
Cardiovascular Biomarkers

Interventions

No intervention

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Actual

Primary Completion Date

Apr 1, 2024Actual

Completion Date

Jul 1, 2024Actual

First Submitted Date

May 10, 2023

First Submission Date that Met QC Criteria

Aug 22, 2023

First Posted Date

Aug 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 8, 2026Actual

Name	Class
Institut Curie	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active surveillance by means of troponin measurements			Other: No intervention
No active surveillance by means of troponin measurements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Active surveillance by means of troponin measurements

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major cardiovascular event	Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death	5 years

Secondary Outcomes

Measure	Description	Time Frame
Completion of cancer therapy as scheduled	Cardiovascular contre indication to immune checkpoint inhibitors	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adult solid cancer patients receiving immune checkpoint inhibitors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mariana Mirabel, MD, PhD	Institut Mutualiste Montsouris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Mutualiste Montsouris		Paris		75014	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided