Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"

Not Applicable

Recruiting

• Conditions: Cardiovascular Prognosis
• Interventions: Biological: blood samples

• Registration Number: NCT03492528
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Each patient will be monitored for 5 years. Cardio-oncological follow-up and management within these centers will follow a common protocol established and validated in March 2016 on the basis of international recommendations and summaries of the characteristics produced for each drug. Additional blood samples will be taken for the biobanking. Depending on the case, a small skin biopsy will be carried out to analyze the cardiovascular response of in vitro immunotherapy using a reprogramming model of fibroblasts in hiPSC hiPSC (human induced Pluripotent Stem cells)-cardiomyocytes.

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-10
• Study Start: 2019-07-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21
• Primary Completion: 2027-04
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

• All adults referred for specialist cardio-oncology consultations before the initiation of a cancer treatment according to pre-established indications will be eligible.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiovascular patients treated for a cancer	blood samples	-

Primary Outcome Measures

Name	Time	Method
Dosage of cardiac biomarkers	5 YEARS	dosage of troponine

Trial Locations

Locations (1)

Assiatnce Publique Hopitaux de Marseille; 🇫🇷 Marseille, France