Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"

NCT ID: NCT03492528

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2027-10-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Prognosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cardiovascular patients treated for a cancer

Group Type EXPERIMENTAL

blood samples

Intervention Type BIOLOGICAL

blood samples

Interventions

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blood samples

blood samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jean-olivier ARNAUD

Role: STUDY_DIRECTOR

Assistance Publique-Hôpitaux de Marseille

Locations

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Assiatnce Publique Hopitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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franck thuny

Role: CONTACT

33(0)4 91 96 86 83

Facility Contacts

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FRANCK THUNY

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31988143 (View on PubMed)

Other Identifiers

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2017-A03362-51

Identifier Type: OTHER

Identifier Source: secondary_id

2017-50

Identifier Type: -

Identifier Source: org_study_id

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