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Cardiovascular Outcome of Cancer Patients: The GMEDICO Cohort

Cardiovascular Outcome of Cancer Patients: The GMEDICO Cohort

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03492528
Acronym
GMEDICO
Enrollment
530
Registered
2018-04-10
Start date
2019-07-05
Completion date
2027-10-31
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Prognosis

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.

Interventions

BIOLOGICALblood samples

blood samples

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dosage of cardiac biomarkers5 YEARSdosage of troponine

Countries

France

Contacts

Primary Contactfranck thuny
franck.thuny@ap-hm.fr33(0)4 91 96 86 83

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026