Late cardiac adverse events in patients with cancer treated with immune checkpoint inhibitors.
Charles Dolladille, Stephane Ederhy, Stéphane Allouche...
https://pubmed.ncbi.nlm.nih.gov/31988143Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03492528
Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"
Led by Assistance Publique Hopitaux De Marseille · Updated on 2022-09-21
530
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Mediterranean Group of Cardio-Oncology (GMEDICO) is conducting research to understand the cardiovascular outcomes of patients treated for cancer. This study aims to identify the chances of heart-related problems and find factors that predict cardiovascular events in cancer patients. It also seeks to create a biological collection for testing biomarkers and genetic factors linked to cardiovascular events during cancer treatment. Participants will be monitored for 5 years following a standardized cardio-oncology protocol based on international guidelines and drug-specific information. The study involves regular cardio-oncological follow-ups and management within specialized centers. Additional blood samples will be collected for biobanking. In some cases, a small skin biopsy may be performed to study the heart's response to immunotherapy using advanced cell models. Throughout the study, participants will have cardiac biomarkers measured at regular intervals over 5 years. Researchers will monitor heart health using clinical assessments, biological tests, and imaging methods. Data collected will help develop risk scores for cardiovascular events during cancer treatment. The study is led by Assistance Publique Hopitaux De Marseille and includes careful long-term follow-up and management of participants' cardiovascular health.
CONDITIONS
Brief Title
Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults referred for specialist cardio-oncology consultations before starting cancer treatment
You will not qualify if you...
- Unable or unwilling to provide information or sign consent forms
- Minor or adult under legal guardianship
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Initial period before follow-up
Participants undergo blood sample collection and may have a small skin biopsy to analyze cardiovascular response related to cancer treatment.
1 to 2 visits depending on assessments
Long-term Monitoring
Duration - 5 years
Participants are monitored for cardiovascular outcomes and biomarker levels over 5 years with cardio-oncological follow-up and management following established protocols.
Regular visits as per cardio-oncology follow-up protocol
Trial Site Locations
Total: 1 location
1
Assiatnce Publique Hopitaux de Marseille
Marseille, France, 13354
Actively Recruiting
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Research Team
F
franck thuny
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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