Cardio-Oncology Registry

Cancer Clinical Trial

— CONFUCIUS  

Official title:

Cardio-Oncologie: étude Pilote évaluant la faisabilité, Utilité Concrète, Interdisciplinaire d'Une Unité Spécialisée

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04407780
• Other study ID #: 00011928
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: June 1, 2027

Study information

• Verified date: May 2020
• Source: European Georges Pompidou Hospital
• Contact: Mariana Mirabel, MD, PhD
• Phone: +33156095636
• Email: mariana.mirabel[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cardio-oncology is an emerging field. Most of the data available have been issued from either retrospective analysis, industry data or pharmacovigilance data. These data sources include a number of bias.

CONFUCIUS is a single tertiary centre prospective registry including all patients who have been referred for cardio-oncology assessemnt.

The objectives are to provide a comprehensive vue of cardoi-oncology, enable to detect early signals of cardiotoxicity and enhance ancillary projetcts aiming at specific populations (e.g., type of cancer) and/or drugs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• referred to cardio-oncology

Exclusion Criteria:

• refusal to participate

Related Conditions & MeSH terms

• Arrhythmia
• Cancer
• Cardiac Disease
• Heart Diseases
• Metabolic Syndrome

Intervention

Other:
• No interventions are planned
Non applicable

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - Centre Université de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardio-toxicty	Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic	5 years
Secondary	Analysis of cardiotoxicity	Correlation of cardio-toxicity overall, and in predefined subgroups; statistical associatoin with outcomes.	5 years
Secondary	Analysis of cardioprotective strategies	Correlation between the use of cardiovascular drugs and the number of patients with cardiotoxicity.	5 years
Secondary	Analysis of underlying cardiovacsular profile	Correlation between underlying cardioascular profile and the number of patients with cardiotoxicity.	5 years
Secondary	Analysis of arrhythmias	Correlation between incident arrhythmias and cancer drugs	5 years
Secondary	Precision medicine	Correlation between biomarkers with use of artificial intelligence and the number of patients with cardiotoxicity.	5 years
Secondary	Oncology	Adherence to oncology treatment plan as stated in the multidisciplinary team meeting in patients with cardio-oncology assessment compared to matched patients with no cardio-oncology assessment within our institution; outcomes.	5 years
Secondary	Cardiovascular outcomes	Assess cardiovascular outcomes (cardiovascular death, admission for heart failure, acute coronary syndrome, stroke).	10 years
Secondary	Any advserse event	Correlation between any adverse event, oncology treatment, and outcomes.	5 years
Secondary	Behaviour	Correlation of any behaviour treatment (exercice, rehabilitation, nutrition consultation) and the number of patents with cardiotoxocity.	5 years
Secondary	Metabolic	Correlation between oncology treatments, cardiovascular therapies, behaviour therapies and the number of patients with metabolic disorders (diabetes or dyslipidemia).	5 years

External Links

•   Assistance Publique Hôpitaux de Paris' webinar
•   Hospital website