Trials / Recruiting
RecruitingNCT03492528
Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 530 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | blood samples | blood samples |
Timeline
- Start date
- 2019-07-05
- Primary completion
- 2027-04-01
- Completion
- 2027-10-01
- First posted
- 2018-04-10
- Last updated
- 2022-09-21
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03492528. Inclusion in this directory is not an endorsement.