CancerCONFUCIUSNCT04407780
Cardio-Oncology Registry
An observational study of Cancer and Cardiac Disease, run by European Georges Pompidou Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cardiac Disease, Metabolic Syndrome
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 1 Jun 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- referred to cardio-oncology
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - Centre Université de Paris
Paris, 75015
Mariana Mirabel, MD, PhD, +33156095636, mariana.mirabel@aphp.fr
About this study
Official title: 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.
- Conditions
- Cancer, Cardiac Disease, Metabolic Syndrome, Arrhythmia, Heart Diseases
- Being tested
- No interventions are planned
- Keywords
- cancer, heart, cardiovascular, cardio-oncology, onco-cardiology, phamacology, precision medicine
- Medical subject headings
- Neoplasms, Heart Diseases, Metabolic Syndrome, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions are plannedOther
Non applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardio-toxicty
Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic
Measured: 5 years
Secondary outcomes (10)
Analysis of cardiotoxicity
Correlation of cardio-toxicity overall, and in predefined subgroups; statistical associatoin with outcomes.
Measured: 5 years
Analysis of cardioprotective strategies
Correlation between the use of cardiovascular drugs and the number of patients with cardiotoxicity.
Measured: 5 years
Analysis of underlying cardiovacsular profile
Correlation between underlying cardioascular profile and the number of patients with cardiotoxicity.
Measured: 5 years
Analysis of arrhythmias
Correlation between incident arrhythmias and cancer drugs
Measured: 5 years
Precision medicine
Correlation between biomarkers with use of artificial intelligence and the number of patients with cardiotoxicity.
Measured: 5 years
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.
Measured: 5 years
Cardiovascular outcomes
Assess cardiovascular outcomes (cardiovascular death, admission for heart failure, acute coronary syndrome, stroke).
Measured: 10 years
Any advserse event
Correlation between any adverse event, oncology treatment, and outcomes.
Measured: 5 years
Behaviour
Correlation of any behaviour treatment (exercice, rehabilitation, nutrition consultation) and the number of patents with cardiotoxocity.
Measured: 5 years
Metabolic
Correlation between oncology treatments, cardiovascular therapies, behaviour therapies and the number of patients with metabolic disorders (diabetes or dyslipidemia).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jan 2017
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Mirabel, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407780
- Sponsor's protocol ID
- 00011928
- Acronym
- CONFUCIUS
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-Oncologie: étude Pilote évaluant la faisabilité, Utilité Concrète, Interdisciplinaire d'Une Unité Spécialisée
- ClinicalTrials.gov ID
- NCT04407780
- Acronym / sponsor ID
- CONFUCIUS / 00011928
- Conditions
- Cancer, Cardiac Disease, Metabolic Syndrome, Arrhythmia, Heart Diseases
- Keywords
- cancer, heart, cardiovascular, cardio-oncology, onco-cardiology, phamacology, precision medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- referred to cardio-oncology
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions are plannedNon applicable | Other | – |
Primary outcome
Incidence of cardio-toxicty
Time frame: 5 years
Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic
10 secondary outcomes
Analysis of cardiotoxicity
Time frame: 5 years
Analysis of cardioprotective strategies
Time frame: 5 years
Analysis of underlying cardiovacsular profile
Time frame: 5 years
Analysis of arrhythmias
Time frame: 5 years
Precision medicine
Time frame: 5 years
Oncology
Time frame: 5 years
Cardiovascular outcomes
Time frame: 10 years
Any advserse event
Time frame: 5 years
Behaviour
Time frame: 5 years
Metabolic
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Hospital websiteLink provided by the sponsor.
- Assistance Publique Hôpitaux de Paris' webinarLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cardiac Disease, run by European Georges Pompidou Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Mirabel, MD, PhD (+33156095636, mariana.mirabel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardio-toxicty (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.