CancerTILTNCT06007274
Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors
An observational study of Cancer and Immune Checkpoint Inhibitor, run by Institut Mutualiste Montsouris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Immune Checkpoint Inhibitor, Cardiovascular Biomarkers
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult solid cancer patients receiving immune checkpoint inhibitors
Who may be able to join
- All solid cancer patients treated by immune checkpoint inhibitors 2017-2022
Who cannot join
- Patients enrolled in an invterventional study (e.g., pharma trial)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Troponin to Detect Major Cardiovasculaire Advserse Events on Immune: a Case Control Retrospective Study
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.
Read the 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.
- Being tested
- No intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Active surveillance by means of troponin measurements | Not described Receives: Other: No intervention | |
| No active surveillance by means of troponin measurements | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular event
Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death
Measured: 5 years
Secondary outcomes (1)
Completion of cancer therapy as scheduled
Cardiovascular contre indication to immune checkpoint inhibitors
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Apr 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Curie
- Responsible party
- Sponsor
- Investigators
- Mariana Mirabel, MD, PhD, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007274
- Sponsor's protocol ID
- CARDIO-04-2022
- Acronym
- TILT
- Status last verified
- Apr 2026
- First submitted
- 10 May 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Troponin to Detect Major Cardiovasculaire Advserse Events on Immune: a Case Control Retrospective Study
- ClinicalTrials.gov ID
- NCT06007274
- Acronym / sponsor ID
- TILT / CARDIO-04-2022
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Collaborators
- Institut Curie
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active surveillance by means of troponin measurements | – | Other: No intervention |
| No active surveillance by means of troponin measurements | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult solid cancer patients receiving immune checkpoint inhibitors
Key inclusion criteria (1 listed)
- All solid cancer patients treated by immune checkpoint inhibitors 2017-2022
Key exclusion criteria (1 listed)
- Patients enrolled in an invterventional study (e.g., pharma trial)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Active surveillance by means of troponin measurements |
Primary outcome
Major cardiovascular event
Time frame: 5 years
Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death
1 secondary outcome
Completion of cancer therapy as scheduled
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Mirabel, MD, PhD principal investigator
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Immune Checkpoint Inhibitor, run by Institut Mutualiste Montsouris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular event (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.