ClinicalTrials.gg
RecruitingNCT05799898FAST-TRACKUpdated Apr 5, 2023

Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors

An observational study in Cancer, Immune Checkpoint Inhibitor and Cardiovascular Complication, sponsored by Institut Mutualiste Montsouris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-05.

Sponsored by Institut Mutualiste Montsouris · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2023, 3 years 4 months ago, but the record still lists the study as recruiting.
  • Started Mar 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

Prospective study cohort on patients addressed for suspected cardiovascular event on immune checkpoint inchibitors.

Longitudinal prospective single center cohort. Inclusion criteria: all patient willing to particiupate seen in the cardio-oncology unit at our institution for the suspicion of heart failure, atherosclerosis related event, Tako Tsubo, arrhymias, pericarditis, myocarditis on antiPD1, antiPDL1, or antiCTLA4 immune checkpoint inhibitors.

Description of patients characteristics, investigations, diagnosis after multidisciplinary meeting, outcomes.

02

Conditions studied

  • Cancer
  • Immune Checkpoint Inhibitor
  • Cardiovascular Complication
  • Immune-related Adverse Event

Browse trials for

03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Institut Mutualiste Montsouris is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults on immune checkpoint inhibitors for cancer treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patient referred to the cardio oncology unit for suspected immune related cardiovascular complication on

Exclusion criteria

Exclusion Criteria:

  • none
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherNo intervention for research purposes only

    No intervention for research purposes only

06

What researchers measure

Primary outcomes

  1. Major cardiovascular event

    Composite endpoint: acute coronary syndrome, myocarditis, pericarditis, heart failure, Taki Tsubo, ventricvular arrhymias

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Intitut Mutualiste Montsouris
    Paris, 75014, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2022 (actual). Primary completion is estimated for Jul 2023, 16 months after the start.

Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's planned 16 months is below that.

Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2023
First posted
Apr 5, 2023
StartActual
Mar 1, 2022
Primary completionEst.
Jul 1, 2023
CompletionEst.
Jan 1, 2030
Last update
Apr 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05799898
Lead sponsor
Institut Mutualiste Montsouris
Responsible party
Sponsor
First posted
Apr 5, 2023
Start date
Mar 1, 2022
Primary completion
Jul 1, 2023 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Apr 5, 2023

Study contacts

Isabelle Sauret
Contact
isabelle.sauret@imm.fr
+33156616705
Nathalie Bass
Contact
nathalie.bass@imm.fr
Mariana Mirabel, MD, PhD
principal investigator · Institut Mutualiste Montsouris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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