Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"

Cardiovascular Prognosis Clinical Trial

— GMEDICO  

Official title:

Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03492528
• Other study ID #: 2017-50
• Secondary ID: 2017-A03362-51
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: October 2027

Study information

• Verified date: September 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: franck thuny
• Phone: 33(0)4 91 96 86 83
• Email: franck.thuny[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: October 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Prognosis

Intervention

Biological:
• blood samples
blood samples

Locations

Country	Name	City	State
France	Assiatnce Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of cardiac biomarkers	dosage of troponine	5 YEARS