Atrial Fibrillation and Cancer: a Nationwide French Cohor... | NCT05563883

Studies
Atrial Fibrillation and Cancer: a Nationwide French Cohort Study

NCT05563883

Sponsor

University Hospital, Caen

Status

Active, not recruiting

Last Update Posted

Oct 3, 2022Actual

Enrollment

5,000,000Estimated

Phase

Not provided

Conditions

Atrial Fibrillation
Cancer
Thromboembolism
Bleeding

Interventions

event occurence

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2022Actual

Primary Completion Date

Jan 2030Estimated

Completion Date

Jan 2030Estimated

First Submitted Date

Sep 24, 2022

First Submission Date that Met QC Criteria

Sep 29, 2022

First Posted Date

Oct 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2022

Last Update Posted Date

Oct 3, 2022Actual

Name	Class
University Hospital, Tours	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

The objective of this study is to use a very large French nationwide cohort to adress thèses questions.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
event occurence	Other	occurence of an event of interest: (AF, cancer, thromboembolism, bleeding, mortality...

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
atrial fibrillation	occurrence of atrial fibrillation	from inclusion in the cohort up to 10 years
cancer	occurrence of cancer	ffrom inclusion in the cohort up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
thromboembolism	occurrence of thromboembolism	from inclusion in the cohort up to 10 years
bleeding	occurrence of bleeding	from inclusion in the cohort up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients hospitalized from january 2010 to december 2019 and having an available ICD-10 code discharge.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Cardiologie, Centre Hospitalier Universitaire Trousseau		Tours		37000	France

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D009369	Neoplasms
D013923	Thromboembolism
D006470	Hemorrhage

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided