NCT04297085

Brief Summary

The main objective of the BREIZH-Cohorte study is to determine the incidence of recurrent short, medium and long-term thromboembolic venous disease as well as risk factors for recurrence in two specific populations: patients under 50 years of age, men and women (5 year recurrence), as well as cancer patients (all ages) (1 year recurrence).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,400

participants targeted

Target at P75+ for not_applicable

Timeline
291mo left

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
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 Progress20%
May 2020Apr 2050

First Submitted

Initial submission to the registry

March 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 28, 2020

Completed
29.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2050

Last Updated

September 12, 2025

Status Verified

December 1, 2024

Enrollment Period

29.9 years

First QC Date

March 4, 2020

Last Update Submit

September 8, 2025

Conditions

Thromboembolic Venous Disease

Outcome Measures

Primary Outcomes (1)

  • Recurrence of thromboembolic venous disease

    Recurrence of thromboembolic venous disease will be established at the end of patient monitoring

    20 years

Secondary Outcomes (4)

  • Haemorrhages under anticoagulant

    20 years

  • Mortality

    20 years

  • Arterial complications

    20 years

  • Long-term complications

    20 years

Study Arms (1)

Cases

EXPERIMENTAL
Biological: Biologic sample

Interventions

Biologic sampleBIOLOGICAL

Biological samples will be taken from the subjects included

Cases

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject aged 18 or over, or a minor with the consent of the parents and the minor, presenting with a thromboembolic venous disease
  • and under or any age if active cancer
  • Affiliated to social security
  • Accepting to participate in the study.

You may not qualify if:

  • Inability to communicate (comprehension disorder).
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHRU Brest

Brest, 29200, France

RECRUITING

HIA Clermont Tonnerre Brest

Brest, 29200, France

RECRUITING

CH Morlaix

Morlaix, 29672, France

RECRUITING

CH de Cornouaille

Quimper, 29107, France

RECRUITING

Study Officials

  • Francis COUTURAUD, MD, PHD

    EA3878 (GETBO), Brest University Hospital in France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis COUTURAUD, MD, PHD

CONTACT

02 98 34 73 47francis.couturaud@chu-brest.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 5, 2020

Study Start

May 28, 2020

Primary Completion (Estimated)

April 1, 2050

Study Completion (Estimated)

April 1, 2050

Last Updated

September 12, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR(4)