- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03492528
Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort" (GMEDICO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: franck thuny
- Phone Number: 33(0)4 91 96 86 83
- Email: franck.thuny@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13354
- Recruiting
- Assiatnce Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cardiovascular patients treated for a cancer
|
blood samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dosage of cardiac biomarkers
Time Frame: 5 YEARS
|
dosage of troponine
|
5 YEARS
|
Collaborators and Investigators
Investigators
- Study Director: jean-olivier ARNAUD, Assistance Publique-Hôpitaux de Marseille
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017-50
- 2017-A03362-51 (OTHER: N°IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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