Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort" (GMEDICO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03492528
Recruitment Status : Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Prognosis Biological: blood samples Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : October 2027

Arm Intervention/treatment
Experimental: Cardiovascular patients treated for a cancer Biological: blood samples
blood samples




Primary Outcome Measures :
  1. Dosage of cardiac biomarkers [ Time Frame: 5 YEARS ]
    dosage of troponine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492528


Contacts
Layout table for location contacts
Contact: franck thuny 33(0)4 91 96 86 83 franck.thuny@ap-hm.fr

Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Layout table for investigator information
Study Director: jean-olivier ARNAUD Assistance Publique-Hôpitaux de Marseille
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03492528    
Other Study ID Numbers: 2017-50
2017-A03362-51 ( Other Identifier: N°IDRCB )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No