NCT05563883

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2022Jan 2030

Study Start

First participant enrolled

September 22, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

7.3 years

First QC Date

September 24, 2022

Last Update Submit

September 29, 2022

Conditions

Atrial FibrillationCancerThromboembolismBleeding

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • thromboembolism

    from inclusion in the cohort up to 10 years

  • bleeding

    from inclusion in the cohort up to 10 years

  • mortality

    from inclusion in the cohort up to 10 years

Interventions

event occurenceOTHER

occurence of an event of interest: (AF, cancer, thromboembolism, bleeding, mortality...

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Cardiologie, Centre Hospitalier Universitaire Trousseau

Tours, 37000, France

Location

MeSH Terms

Conditions

Atrial FibrillationNeoplasmsThromboembolismHemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 24, 2022

First Posted

October 3, 2022

Study Start

September 22, 2022

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

FR(1)