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Trial Title:
Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors
NCT ID:
NCT06007274
Condition:
Cancer
Immune Checkpoint Inhibitor
Cardiovascular Biomarkers
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
No intervention
Arm group label:
Active surveillance by means of troponin measurements
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.
Criteria for eligibility:
Study pop:
All adult solid cancer patients receiving immune checkpoint inhibitors
Sampling method:
Non-Probability Sample
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Recruiting
Contact:
Last name:
Mariana MIRABEL, MD, PhD
Start date:
July 1, 2023
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Institut Mutualiste Montsouris
Agency class:
Other
Collaborator:
Agency:
Institut Curie
Agency class:
Other
Source:
Institut Mutualiste Montsouris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06007274
