Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"
GMEDICO
2 other identifiers
interventional
530
1 country
1
Brief Summary
The Mediterranean Group of Cardio-Oncology (GMEDICO) brings together French cardiologists and oncologists who have developed a protocol for the monitoring and cardio-oncological management of patients treated for cancer. This unique organization makes it possible to envisage the creation of a large cohort from which the incidence and predictive factors of cardiovascular toxicity can be determined. Primary objective: to determine the cardiovascular prognosis of patients treated for cancer and followed up in cardio-oncology. Secondary objectives
- To determine the clinical, biological and imaging factors associated with cardiovascular events under cancer treatment, in order to define a risk score including clinical, biological (biomarker) and imaging data.
- To create a biological source for testing other biomarkers and conducting genome-wide association studies and genetic factors associated with cardiovascular events under cancer treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
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
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedStudy Start
First participant enrolled
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
September 21, 2022
September 1, 2022
7.7 years
April 3, 2018
September 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Dosage of cardiac biomarkers
dosage of troponine
5 YEARS
Study Arms (1)
Cardiovascular patients treated for a cancer
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- All adults referred for specialist cardio-oncology consultations before the initiation of a cancer treatment according to pre-established indications will be eligible.
You may not qualify if:
- Failure to provide information that makes it impossible to complete a consultation form or refuse to sign the consent.
- Minor or major patient under guardianship
- Pregnant or breastfeeding woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiatnce Publique Hopitaux de Marseille
Marseille, 13354, France
Related Publications (1)
Dolladille C, Ederhy S, Allouche S, Dupas Q, Gervais R, Madelaine J, Sassier M, Plane AF, Comoz F, Cohen AA, Thuny FR, Cautela J, Alexandre J. Late cardiac adverse events in patients with cancer treated with immune checkpoint inhibitors. J Immunother Cancer. 2020 Jan;8(1):e000261. doi: 10.1136/jitc-2019-000261.
PMID: 31988143DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
jean-olivier ARNAUD
Assistance Publique-Hôpitaux de Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 10, 2018
Study Start
July 5, 2019
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
September 21, 2022
Record last verified: 2022-09