Thromboembolic Venous DiseaseBREIZH-CohorteNCT04297085
Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence
A study testing Biologic sample in people with Thromboembolic Venous Disease, run by University Hospital, Brest at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thromboembolic Venous Disease
- What is being tested?
- Biologic sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- 4 sitesFrance
- Study dates
- 28 May 2020to Apr 2050
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject aged 18 or over, or a minor with the consent of the parents and the minor, presenting with a thromboembolic venous disease
- 50 and under or any age if active cancer
- Affiliated to social security
- Accepting to participate in the study.
Who cannot join
- Inability to communicate (comprehension disorder).
- Refusal to participate.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHRU Brest
Brest, 29200
Francis Couturaud, Professor, 02 98 34 73 47 ext. +33, francis.couturaud@chu-brest.fr
- Recruiting
HIA Clermont Tonnerre Brest
Brest, 29200
Marc DANGUY DES DESERTS
- Recruiting
CH Morlaix
Morlaix, 29672
Yannick LAMBERT
- Recruiting
CH de Cornouaille
Quimper, 29107
Lenaïg LE CLECH, 02 98 52 67 31
About this study
Official title: Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence. BREIZH-Cohorte
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).
Read the detailed description
Deep vein thrombosis (DVT) and pulmonary embolism (PE) are two clinical manifestations of the same entity, thromboembolic venous disease. This disease is frequent: the annual incidence of thromboembolic venous disease estimated between 1 and 2 cases per 1000 inhabitants per year in France, comparable to that observed in North America. This disease is potentially serious: the mortality from PE, the most severe manifestation of thromboembolic venous disease (one third of PE for two thirds of DVT) is 10% at 3 months, twice as high as that of myocardial infarction. However, the risk of PE in isolated DVT is major (more than 50% of cases). Thus, whether it is a PE or a DVT, anticoagulant treatment, a cornerstone of therapeutic management, must therefore be initiated urgently, without waiting for the results of diagnostic confirmatory examinations.
The major complications occurring after a thromboembolic venous disease are venous thromboembolic recurrence (VTE) and the long-term consequences: post-thrombotic syndrome and the development of post-embolic pulmonary hypertension. VTE recurrence has significant mortality, particularly in the form of PE (15%, compared to 2% in the form of DVT). As for long-term complications of VTE, about 20-30% of patients with DVT develop post-thrombotic syndrome at 5 years (27), while 0.15% to 5% of patients with PE develop post-embolic pulmonary hypertension at 1 year.
While major progress has been made over the past 20 years in terms of diagnosis, primary and secondary prevention, identification of risk factors for VTE and prognostic factors, however, two particular subgroups deserve to be specifically investigated: young subjects, whether women (hormonal exposure) or men (often idiopathic thromboembolic venous disease), and cancer patients. In the latter, the progress made on anti-cancer treatments is helping to modify the data on the risk of VTE as well as the duration of treatment of VTE in these patients.
Thus, this prospective cohort covers two subgroups of patients with thromboembolic venous disease: young subjects (≤50 years) or those who have cancer.
- Conditions
- Thromboembolic Venous Disease
- Being tested
- Biologic sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic sampleBiological
Biological samples will be taken from the subjects included
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | Not described Receives: Biological: Biologic sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of thromboembolic venous disease
Recurrence of thromboembolic venous disease will be established at the end of patient monitoring
Measured: 20 years
Secondary outcomes (4)
Haemorrhages under anticoagulant
Haemorrhages under anticoagulant will be identified during patient follow-up
Measured: 20 years
Mortality
Mortality will be identified during patient follow-up
Measured: 20 years
Arterial complications
Arterial complications will be identified during patient follow-up
Measured: 20 years
Long-term complications
long-term complications (chronic thrombo-embolic pulmonary hypertension, chronic thrombo-embolic disease) will be identified during patient follow-up
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start28 May 2020
- Primary completionApr 2050 (estimated)
- Study completionApr 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboembolic Venous DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis COUTURAUD, MD, PHD, Principal investigator, EA3878 (GETBO), Brest University Hospital in France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297085
- Sponsor's protocol ID
- BREIZH-Cohorte (29BRC19.0304)
- Acronym
- BREIZH-Cohorte
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence. BREIZH-Cohorte
- ClinicalTrials.gov ID
- NCT04297085
- Acronym / sponsor ID
- BREIZH-Cohorte / BREIZH-Cohorte (29BRC19.0304)
- Conditions
- Thromboembolic Venous Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- Apr 2050 (estimated)
- Study completion
- Apr 2050 (estimated)
- First posted
- 5 Mar 2020 (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.
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).
Detailed description
Deep vein thrombosis (DVT) and pulmonary embolism (PE) are two clinical manifestations of the same entity, thromboembolic venous disease. This disease is frequent: the annual incidence of thromboembolic venous disease estimated between 1 and 2 cases per 1000 inhabitants per year in France, comparable to that observed in North America. This disease is potentially serious: the mortality from PE, the most severe manifestation of thromboembolic venous disease (one third of PE for two thirds of DVT) is 10% at 3 months, twice as high as that of myocardial infarction. However, the risk of PE in isolated DVT is major (more than 50% of cases). Thus, whether it is a PE or a DVT, anticoagulant treatment, a cornerstone of therapeutic management, must therefore be initiated urgently, without waiting for the results of diagnostic confirmatory examinations.
The major complications occurring after a thromboembolic venous disease are venous thromboembolic recurrence (VTE) and the long-term consequences: post-thrombotic syndrome and the development of post-embolic pulmonary hypertension. VTE recurrence has significant mortality, particularly in the form of PE (15%, compared to 2% in the form of DVT). As for long-term complications of VTE, about 20-30% of patients with DVT develop post-thrombotic syndrome at 5 years (27), while 0.15% to 5% of patients with PE develop post-embolic pulmonary hypertension at 1 year.
While major progress has been made over the past 20 years in terms of diagnosis, primary and secondary prevention, identification of risk factors for VTE and prognostic factors, however, two particular subgroups deserve to be specifically investigated: young subjects, whether women (hormonal exposure) or men (often idiopathic thromboembolic venous disease), and cancer patients. In the latter, the progress made on anti-cancer treatments is helping to modify the data on the risk of VTE as well as the duration of treatment of VTE in these patients.
Thus, this prospective cohort covers two subgroups of patients with thromboembolic venous disease: young subjects (≤50 years) or those who have cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Biological: Biologic sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subject aged 18 or over, or a minor with the consent of the parents and the minor, presenting with a thromboembolic venous disease
- 50 and under or any age if active cancer
- Affiliated to social security
- Accepting to participate in the study.
Key exclusion criteria (2 listed)
- Inability to communicate (comprehension disorder).
- Refusal to participate.
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 |
|---|---|---|
| Biologic sampleBiological samples will be taken from the subjects included | Biological | Cases |
Primary outcome
Recurrence of thromboembolic venous disease
Time frame: 20 years
Recurrence of thromboembolic venous disease will be established at the end of patient monitoring
4 secondary outcomes
Haemorrhages under anticoagulant
Time frame: 20 years
Mortality
Time frame: 20 years
Arterial complications
Time frame: 20 years
Long-term complications
Time frame: 20 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 15 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Thromboembolic Venous Disease
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Safety of Perioperative Anticoagulation Management in People With Active Cancer Undergoing Cancer-Related Surgery or Procedures (ACE-HIGH Study)
Thrombosis, Cancer
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Variations in the Hemostatic System Induced by a Standardized Walking Test
Venous Thromboembolism
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Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure
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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.
Francis COUTURAUD, MD, PHD principal investigator
EA3878 (GETBO), Brest University Hospital in France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biologic sample in people with Thromboembolic Venous Disease, run by University Hospital, Brest at 4 sites 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Francis COUTURAUD, MD, PHD (02 98 34 73 47 ext. +33, francis.couturaud@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of thromboembolic venous disease (time frame: 20 years). 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 15 Jun 2026.