CONFUCIUS: Cardio-Oncology Registry

Sponsor

European Georges Pompidou Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04407780

Collaborator

(none)

5,000

Enrollment

Location

124.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Cardiac Disease Metabolic Syndrome Arrhythmia Heart Diseases	Other: No interventions are planned

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2027

Outcome Measures

Primary Outcome Measures

Incidence of cardio-toxicty [5 years]
Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic

Secondary Outcome Measures

Analysis of cardiotoxicity [5 years]
Correlation of cardio-toxicity overall, and in predefined subgroups; statistical associatoin with outcomes.
Analysis of cardioprotective strategies [5 years]
Correlation between the use of cardiovascular drugs and the number of patients with cardiotoxicity.
Analysis of underlying cardiovacsular profile [5 years]
Correlation between underlying cardioascular profile and the number of patients with cardiotoxicity.
Analysis of arrhythmias [5 years]
Correlation between incident arrhythmias and cancer drugs
Precision medicine [5 years]
Correlation between biomarkers with use of artificial intelligence and the number of patients with cardiotoxicity.
Oncology [5 years]
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.
Cardiovascular outcomes [10 years]
Assess cardiovascular outcomes (cardiovascular death, admission for heart failure, acute coronary syndrome, stroke).
Any advserse event [5 years]
Correlation between any adverse event, oncology treatment, and outcomes.
Behaviour [5 years]
Correlation of any behaviour treatment (exercice, rehabilitation, nutrition consultation) and the number of patents with cardiotoxocity.
Metabolic [5 years]
Correlation between oncology treatments, cardiovascular therapies, behaviour therapies and the number of patients with metabolic disorders (diabetes or dyslipidemia).