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NCT Number: NCT03492528

Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"

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.

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Key information

Conditions

Cardiovascular Prognosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiatnce Publique Hopitaux de Marseille

Marseille, 13354, France

Location status: Recruiting

Location contact

FRANCK THUNY

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samples

Biological

blood samples

Primary outcomes

  1. Dosage of cardiac biomarkers

    Time frame: 5 YEARS

    dosage of troponine

Study contacts

Contact information is provided by the study sponsor or research team.

franck thuny

CONTACT

[email protected]

33(0)4 91 96 86 83

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: GMEDICO

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2018
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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