Cardio-Oncology Registry (CONFUCIUS)

May 25, 2020 updated by: Mariana Mirabel, European Georges Pompidou Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Assistance Publique Hôpitaux de Paris - Centre Université de Paris
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All prosepctive patients seen in the cardio-oncology clinic. Observational data will be collected from the medical records. Outcomes measures according to scheduled follow-up visits for their cardiovascular health.

Description

Inclusion Criteria:

  • referred to cardio-oncology

Exclusion Criteria:

  • refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cardio-toxicty
Time Frame: 5 years
Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Georges Pompidou Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2027

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 25, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00011928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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