NCT06007274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

May 10, 2023

Last Update Submit

April 2, 2026

Conditions

CancerImmune Checkpoint InhibitorCardiovascular Biomarkers

Outcome Measures

Primary Outcomes (1)

  • Major cardiovascular event

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

    5 years

Secondary Outcomes (1)

  • Completion of cancer therapy as scheduled

    5 years

Study Arms (2)

Active surveillance by means of troponin measurements

Other: No intervention

No active surveillance by means of troponin measurements

Interventions

No interventionOTHER

No intervention

Active surveillance by means of troponin measurements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult solid cancer patients receiving immune checkpoint inhibitors

You may qualify if:

  • All solid cancer patients treated by immune checkpoint inhibitors 2017-2022

You may not qualify if:

  • Patients enrolled in an invterventional study (e.g., pharma trial)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Mariana Mirabel, MD, PhD

    Institut Mutualiste Montsouris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

August 23, 2023

Study Start

July 1, 2023

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

FR(1)