CancerAFIB-CANCERNCT04696081
Atrial Fibrillation in Active Cancer Patients
An observational study of Cancer and Drug Toxicity, run by University Hospital, Caen at 1 site in France.
Trial summary
Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Drug Toxicity, Atrial Fibrillation
- What is being tested?
- occurence of atrial fibrillation
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Jan 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with a cancer will defined as patients with confirmed cancer other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia. Active cancer will be defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, and an anticancer treatment given at the time of enrollment or during 6 months before enrollment (according to Agnelli et al. NEJM 2020). AF patients will be both patients with incident AF (first AF episode diagnosed after cancer diagnosis) and those with prevalent AF (AF recurrence occurring after cancer diagnosis and a first AF episode prior to cancer diagnosis)
Who may be able to join
- adult patients
- outpatients or hospitalized patients
- with a confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia) and an active cancer (defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, for which anticancer treatment was being given at the time of enrollment or during 6 months before enrollment)
- at least 1 episode of atrial fibrillation (new onset AF occuring after cancer diagnosis or history of paroxysmal of persistant AF prior to cancer diagnosis and an AF recurrence after cancer diagnosis)
- in sinus rhythm at the time of cancer diagnosis
Who cannot join
- patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence)
- history of long-standing persistant or permanent AF prior to cancer diagnosis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Alexandre
Caen, Normandy, 14000
Joachim ALEXANDRE, MD, PhD
alexandre-j@chu-caen.fr
About this study
Official title: Multicenter International Prospective Registry to Identify Major Cardiovascular Events Associated With the Occurrence of Atrial Fibrillation in Active Cancer Patients
Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. The objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.
- Being tested
- occurence of atrial fibrillation
- Medical subject headings
- Neoplasms, Drug-Related Side Effects and Adverse Reactions, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occurence of atrial fibrillationOther
all adult patients with an active cancer and experiencing atrial fibrillation will be consecutively include. Active cancers will be defined according Agnelli et al. (NEJM 2020; 382:1599-1607).
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major cardiovascular events and death of any cause at 1 year
Occurrence of death of any cause, cardiovascular death, heart failure, stroke, myocardial infarction in active cancer patients with atrial fibrillation.
Measured: from inclusion in the registry to 1 year of follow-up
Secondary outcomes (8)
Occurrence of major cardiovascular events and death of any cause at 1 year in prevalent and incident AF patients
Occurrence of death of any cause, cardiovascular death, heart failure, stroke, myocardial infarction in active cancer patients according to the AF type (prevalent or incident).
Measured: from inclusion in the registry to 1 year of follow-up
Description of the population of active cancer patients experiencing atrial fibrillation (in both prevalent and incidence AF patients).
Description of the population of active cancer patients experiencing atrial fibrillation. Active cancers will be defined according Agnelli et al. (NEJM 2020; 382:1599-1607).
Measured: at the inclusion in the registry
Description of the management of atrial fibrillation in cancer patients (in both prevalent and incidence AF patients).
Description of the management (anticoagulants, rhythm or rate control) of atrial fibrillation in cancer patients
Measured: from inclusion in the registry to 1 year of follow-up
Description of the population of active cancer patients having a major cardiovascular event
Description of the population of patients having a major cardiovascular event among cancer patients experiencing atrial fibrillation
Measured: from inclusion in the registry to 1 year of follow-up
Identifying risk factors associated with major cardiovascular events and all cause mortality occurrence
Identifying risk factors (clinical, EKG, biological, echocardiography) of major cardiovascular events and all cause mortality in cancer patients experiencing atrial fibrillation
Measured: from inclusion in the registry to 1 year of follow-up
Identifying factors associated with atrial fibrillation recurrence
Identifying factors (clinical, EKG, biological, echocardiography) of atrial fibrillation recurrence in cancer patients
Measured: from inclusion in the registry to 1 year of follow-up
Occurrence of major and clinically relevant non-major bleedings (2005 ISTH definition)
Occurrence of major and clinically relevant non-major bleedings in active cancer patients experiencing atrial fibrillation.
Measured: from inclusion in the registry to 1 year of follow-up
Identifying risk factors associated with major and clinically relevant non-major bleedings (2005 ISTH definition)
Identifying risk factors (clinical, EKG, biological, echocardiography) of major and clinically relevant non-major bleedings in active cancer patients experiencing atrial fibrillation
Measured: from inclusion in the registry to 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Marseille, France, Hospices Civils de Lyon, France, Centre Francois Baclesse, University Hospital of Saint-Etienne, France, Hôpital Lariboisière Fernand Widal, Paris, France, Institut de Cancérologie de l'Ouest Nantes, France, Fundacion Cardio Onco, Santiago, Chile, University of Newcastle, Australia, University Hospital, Rouen
- Responsible party
- Sponsor
- Investigators
- Joachim Alexandre, MD, PhD, Principal investigator, Caen Normandy University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696081
- Sponsor's protocol ID
- Pharmaco122020
- Acronym
- AFIB-CANCER
- Status last verified
- Jul 2024
- First submitted
- 4 Jan 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE. Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24.
PubMed 29698683Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.
PubMed 32353110
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter International Prospective Registry to Identify Major Cardiovascular Events Associated With the Occurrence of Atrial Fibrillation in Active Cancer Patients
- ClinicalTrials.gov ID
- NCT04696081
- Acronym / sponsor ID
- AFIB-CANCER / Pharmaco122020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University Hospital, Marseille, France, Hospices Civils de Lyon, France, Centre Francois Baclesse, University Hospital of Saint-Etienne, France, Hôpital Lariboisière Fernand Widal, Paris, France, Institut de Cancérologie de l'Ouest Nantes, France, Fundacion Cardio Onco, Santiago, Chile, University of Newcastle, Australia, University Hospital, Rouen
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 6 Jan 2021 (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.
Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. The objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a cancer will defined as patients with confirmed cancer other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia. Active cancer will be defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, and an anticancer treatment given at the time of enrollment or during 6 months before enrollment (according to Agnelli et al. NEJM 2020). AF patients will be both patients with incident AF (first AF episode diagnosed after cancer diagnosis) and those with prevalent AF (AF recurrence occurring after cancer diagnosis and a first AF episode prior to cancer diagnosis)
Key inclusion criteria (5 listed)
- adult patients
- outpatients or hospitalized patients
- with a confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia) and an active cancer (defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, for which anticancer treatment was being given at the time of enrollment or during 6 months before enrollment)
- at least 1 episode of atrial fibrillation (new onset AF occuring after cancer diagnosis or history of paroxysmal of persistant AF prior to cancer diagnosis and an AF recurrence after cancer diagnosis)
- in sinus rhythm at the time of cancer diagnosis
Key exclusion criteria (2 listed)
- patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence)
- history of long-standing persistant or permanent AF prior to cancer diagnosis
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 |
|---|---|---|
| occurence of atrial fibrillationall adult patients with an active cancer and experiencing atrial fibrillation will be consecutively include. Active cancers will be defined according Agnelli et al. (NEJM 2020; 382:1599-1607). | Other | – |
Primary outcome
Occurrence of major cardiovascular events and death of any cause at 1 year
Time frame: from inclusion in the registry to 1 year of follow-up
Occurrence of death of any cause, cardiovascular death, heart failure, stroke, myocardial infarction in active cancer patients with atrial fibrillation.
8 secondary outcomes
Occurrence of major cardiovascular events and death of any cause at 1 year in prevalent and incident AF patients
Time frame: from inclusion in the registry to 1 year of follow-up
Description of the population of active cancer patients experiencing atrial fibrillation (in both prevalent and incidence AF patients).
Time frame: at the inclusion in the registry
Description of the management of atrial fibrillation in cancer patients (in both prevalent and incidence AF patients).
Time frame: from inclusion in the registry to 1 year of follow-up
Description of the population of active cancer patients having a major cardiovascular event
Time frame: from inclusion in the registry to 1 year of follow-up
Identifying risk factors associated with major cardiovascular events and all cause mortality occurrence
Time frame: from inclusion in the registry to 1 year of follow-up
Identifying factors associated with atrial fibrillation recurrence
Time frame: from inclusion in the registry to 1 year of follow-up
Occurrence of major and clinically relevant non-major bleedings (2005 ISTH definition)
Time frame: from inclusion in the registry to 1 year of follow-up
Identifying risk factors associated with major and clinically relevant non-major bleedings (2005 ISTH definition)
Time frame: from inclusion in the registry to 1 year of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 29698683Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE. Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24.
- Background: PubMed 32353110Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.
- 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. This study is not recruiting at the moment.
Joachim Alexandre, MD, PhD principal investigator
Caen Normandy University Hospital, France
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 Drug Toxicity, run by University Hospital, Caen 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joachim Alexandre, MD, PhD (+330231064770, alexandre-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major cardiovascular events and death of any cause at 1 year (time frame: from inclusion in the registry to 1 year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696081, which also lists 2 linked publications.
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 9 Aug 2024.