Atrial FibrillationNCT05563883
Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
An observational study of Atrial Fibrillation and Cancer, run by University Hospital, Caen at 1 site in France.
Trial summary
Atrial fibrillation (AF) is a common complication associated with cancer but the risk of AF according to the cancer localization and status as well as the risk of thromboembolisms, bleedings and mortality are poorly known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Cancer, Thromboembolism
- What is being tested?
- event occurence
- How many people
- 5,000,000 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2022to Jan 2030
- 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
- Adult, Older adult
Study population: Patients hospitalized from january 2010 to december 2019 and having an available ICD-10 code discharge.
Who may be able to join
- adult hospitalized patients
- with an ICD-10 code discharge from january 2010 to december 2019 in the French national hospital discharge database (PMSI Programme de Médicalisation des Systèmes d'Information)
Who cannot join
- children
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Cardiologie, Centre Hospitalier Universitaire Trousseau
Tours, 37000
About this study
Atrial fibrillation (AF) is a common complication associated with cancer but the risk of AF according to the cancer localization and status as well as the risk of thromboembolisms, bleedings and mortality are poorly known.
The objective of this study is to use a very large French nationwide cohort to adress thèses questions.
- Conditions
- Atrial Fibrillation, Cancer, Thromboembolism, Bleeding
- Being tested
- event occurence
- Medical subject headings
- Atrial Fibrillation, Neoplasms, Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
event occurenceOther
occurence of an event of interest: (AF, cancer, thromboembolism, bleeding, mortality...
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation
occurrence of atrial fibrillation
Measured: from inclusion in the cohort up to 10 years
cancer
occurrence of cancer
Measured: ffrom inclusion in the cohort up to 10 years
Secondary outcomes (3)
thromboembolism
occurrence of thromboembolism
Measured: from inclusion in the cohort up to 10 years
bleeding
occurrence of bleeding
Measured: from inclusion in the cohort up to 10 years
mortality
occurrence of mortality
Measured: from inclusion in the cohort up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start22 Sep 2022
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Retrospective
- Enrolment
- 5,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours
- Responsible party
- Principal investigator, Joachim ALEXANDRE, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563883
- Sponsor's protocol ID
- PMSI_092022
- Status last verified
- Sep 2022
- First submitted
- 24 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
- ClinicalTrials.gov ID
- NCT05563883
- Acronym / sponsor ID
- PMSI_092022
- Conditions
- Atrial Fibrillation, Cancer, Thromboembolism, Bleeding
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University Hospital, Tours
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 3 Oct 2022 (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 (AF) is a common complication associated with cancer but the risk of AF according to the cancer localization and status as well as the risk of thromboembolisms, bleedings and mortality are poorly known.
The objective of this study is to use a very large French nationwide cohort to adress thèses questions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized from january 2010 to december 2019 and having an available ICD-10 code discharge.
Key inclusion criteria (2 listed)
- adult hospitalized patients
- with an ICD-10 code discharge from january 2010 to december 2019 in the French national hospital discharge database (PMSI Programme de Médicalisation des Systèmes d'Information)
Key exclusion criteria (1 listed)
- children
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 |
|---|---|---|
| event occurenceoccurence of an event of interest: (AF, cancer, thromboembolism, bleeding, mortality... | Other | – |
Primary outcome
atrial fibrillation
Time frame: from inclusion in the cohort up to 10 years
occurrence of atrial fibrillation
cancer
Time frame: ffrom inclusion in the cohort up to 10 years
occurrence of cancer
3 secondary outcomes
thromboembolism
Time frame: from inclusion in the cohort up to 10 years
bleeding
Time frame: from inclusion in the cohort up to 10 years
mortality
Time frame: from inclusion in the cohort up to 10 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 3 Oct 2022.
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atrial Fibrillation and Cancer, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrillation (time frame: from inclusion in the cohort up to 10 years). The study lists 2 primary outcomes in all. 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 3 Oct 2022.