NCT05799898

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress53%
Mar 2022Jan 2030

Study Start

First participant enrolled

March 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

March 23, 2023

Last Update Submit

March 23, 2023

Conditions

CancerImmune Checkpoint InhibitorCardiovascular ComplicationImmune-related Adverse Event

Outcome Measures

Primary Outcomes (1)

  • Major cardiovascular event

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

    12 months

Interventions

No intervention for research purposes onlyOTHER

No intervention for research purposes only

Eligibility Criteria

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

Adults on immune checkpoint inhibitors for cancer treatment

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intitut Mutualiste Montsouris

Paris, 75014, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endomyocardial biopsies

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Mariana Mirabel, MD, PhD

    Institut Mutualiste Montsouris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Sauret

CONTACT

+33156616705isabelle.sauret@imm.fr

Nathalie Bass

CONTACT

nathalie.bass@imm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 5, 2023

Study Start

March 1, 2022

Primary Completion

July 1, 2023

Study Completion (Estimated)

January 1, 2030

Last Updated

April 5, 2023

Record last verified: 2023-03

Locations

FR(1)