- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05563883
Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
September 29, 2022 updated by: Joachim ALEXANDRE, University Hospital, Caen
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
5000000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tours, France, 37000
- Service de Cardiologie, Centre Hospitalier Universitaire Trousseau
-
-
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
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized from january 2010 to december 2019 and having an available ICD-10 code discharge.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- children
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 |
|---|---|---|
|
atrial fibrillation
Time Frame: from inclusion in the cohort up to 10 years
|
occurrence of atrial fibrillation
|
from inclusion in the cohort up to 10 years
|
|
cancer
Time Frame: ffrom inclusion in the cohort up to 10 years
|
occurrence of cancer
|
ffrom inclusion in the cohort up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
thromboembolism
Time Frame: from inclusion in the cohort up to 10 years
|
occurrence of thromboembolism
|
from inclusion in the cohort up to 10 years
|
|
bleeding
Time Frame: from inclusion in the cohort up to 10 years
|
occurrence of bleeding
|
from inclusion in the cohort up to 10 years
|
|
mortality
Time Frame: from inclusion in the cohort up to 10 years
|
occurrence of mortality
|
from inclusion in the cohort up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
September 22, 2022
Primary Completion (Anticipated)
January 1, 2030
Study Completion (Anticipated)
January 1, 2030
Study Registration Dates
First Submitted
September 24, 2022
First Submitted That Met QC Criteria
September 29, 2022
First Posted (Actual)
October 3, 2022
Study Record Updates
Last Update Posted (Actual)
October 3, 2022
Last Update Submitted That Met QC Criteria
September 29, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMSI_092022
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.