NCT04407780

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2017Jun 2027

Study Start

First participant enrolled

January 1, 2017

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

5.4 years

First QC Date

May 14, 2020

Last Update Submit

May 25, 2020

Conditions

Keywords

cancerheartcardiovascularcardio-oncologyonco-cardiologyphamacologyprecision medicine

Outcome Measures

Primary Outcomes (1)

  • Incidence of cardio-toxicty

    Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic

    5 years

Secondary Outcomes (10)

  • Analysis of cardiotoxicity

    5 years

  • Analysis of cardioprotective strategies

    5 years

  • Analysis of underlying cardiovacsular profile

    5 years

  • Analysis of arrhythmias

    5 years

  • Precision medicine

    5 years

  • +5 more secondary outcomes

Interventions

Non applicable

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • referred to cardio-oncology

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - Centre Université de Paris

Paris, 75015, France

RECRUITING

Related Links

MeSH Terms

Conditions

NeoplasmsHeart DiseasesMetabolic SyndromeArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mariana Mirabel, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assosiate Professor

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 29, 2020

Study Start

January 1, 2017

Primary Completion

June 1, 2022

Study Completion (Estimated)

June 1, 2027

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations