Venous ThromboembolismMC-MORPHEUSNCT07328152
CoMbination of Data From European Cohorts as Part of the European MORPHEUS Project [HORIZON-HLTH-2022-11-01] - "MC-MORPHEUS".
An observational study of Venous Thromboembolism, run by University Hospital, Brest at 1 site in France.
Trial summary
Combine clinical, biological and morphological data from 14 French and European cohorts into a single database. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to 30 Dec 2029
- Phase
- Observational
- 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
Study population: Patients with MVTE who participated in one of the 14 French or European cohorts
Who may be able to join
- Cohorts led by members of the European MORPHEUS project consortium European MORPHEUS project
Who cannot join
- Lack of consent in cohorts
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Brest
Brest, 29609
Francis COUTURAUD, +00332 98 34 73 47, francis.couturaud@chu-brest.fr
Hélène FORTIN PRUNIER, helene.fortin-prunier@chu-brest.fr
About this study
Combine clinical, biological and morphological data from 14 French and European cohorts into a single database.
Read the detailed description
The MORPHEUS project is an international translational research programme selected and funded by the European call for proposals HORIZON-HLTH-2022-TOOL-11-01. This programme is coordinated by France (Brest University Hospital, INNOVTE, Inserm). This programme brings together all scientific disciplines and involves eight European countries: France, the Netherlands, Spain, Germany, Switzerland, Poland, Sweden and Denmark.
Based on quantitative and qualitative approaches, the MORPHEUS project will combine clinical, biological and morphological biomarkers (precision medicine: based on systematic literature reviews and cohort fusion) and socio-anthropological markers (personalised medicine: socio-anthropological interviews) in a risk prediction tool integrated into a shared medical decision-making process to aid therapeutic decision-making (duration and treatment modalities). The objective is to validate a time-dependent, multi-level tool integrated into a shared medical decision-making process to optimise long-term treatment of unprovoked venous thromboembolic disease (VTED) in a randomised stepped wedge cluster trial.
MC-MORPHEUS is a key phase of the MORPHEUS project aimed at identifying discriminatory biomarkers predictive of risk (thromboembolic recurrence, bleeding, mortality) that will form the basis of the MORPHEUS project's prediction tool.
The aim of the 'MC-MORPHEUS' project is therefore to combine, in a single database, clinical, biological and morphological data from European cohort databases of patients with VTE who have been monitored over several months and years. This combination of European cohort databases will increase the chances of identifying discriminating clinical, biological and morphological biomarkers for risk prediction. The identified and selected biomarkers will then be incorporated into the risk prediction tool, which will be validated in the ETHER cluster study of the MORPHEUS programme.
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism, pulmonary embolism, Anticoagulant, deep vein thrombosis
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency between merged data and initial data from each cohort
The primary outcome is the consistency between the merged dataset and the original data from each cohort, assessed by comparing key variables across sources to ensure data integrity and accuracy. Consistency will be defined as the absence of significant discrepancies in predefined variables, such as demographic characteristics, baseline measures, and primary endpoints.
Measured: Processing of data from the fourth quarter of 2024 to the third quarter of 2025.
Secondary outcomes (3)
Risk of thromboembolic recurrence
Measured: 20 YEARS
Risk of hemorrhagic complications
Measured: 20 YEARS
Risk of death
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 posted9 Jan 2026
- Study start1 May 2024
- Primary completion30 Jun 2024
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328152
- Sponsor's protocol ID
- 29BRC24.0090 - MC-MORPHEUS
- Acronym
- MC-MORPHEUS
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 9 Jan 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoMbination of Data From European Cohorts as Part of the European MORPHEUS Project [HORIZON-HLTH-2022-11-01] - "MC-MORPHEUS".
- ClinicalTrials.gov ID
- NCT07328152
- Acronym / sponsor ID
- MC-MORPHEUS / 29BRC24.0090 - MC-MORPHEUS
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism, pulmonary embolism, Anticoagulant, deep vein thrombosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 9 Jan 2026 (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.
Combine clinical, biological and morphological data from 14 French and European cohorts into a single database.
Detailed description
The MORPHEUS project is an international translational research programme selected and funded by the European call for proposals HORIZON-HLTH-2022-TOOL-11-01. This programme is coordinated by France (Brest University Hospital, INNOVTE, Inserm). This programme brings together all scientific disciplines and involves eight European countries: France, the Netherlands, Spain, Germany, Switzerland, Poland, Sweden and Denmark.
Based on quantitative and qualitative approaches, the MORPHEUS project will combine clinical, biological and morphological biomarkers (precision medicine: based on systematic literature reviews and cohort fusion) and socio-anthropological markers (personalised medicine: socio-anthropological interviews) in a risk prediction tool integrated into a shared medical decision-making process to aid therapeutic decision-making (duration and treatment modalities). The objective is to validate a time-dependent, multi-level tool integrated into a shared medical decision-making process to optimise long-term treatment of unprovoked venous thromboembolic disease (VTED) in a randomised stepped wedge cluster trial.
MC-MORPHEUS is a key phase of the MORPHEUS project aimed at identifying discriminatory biomarkers predictive of risk (thromboembolic recurrence, bleeding, mortality) that will form the basis of the MORPHEUS project's prediction tool.
The aim of the 'MC-MORPHEUS' project is therefore to combine, in a single database, clinical, biological and morphological data from European cohort databases of patients with VTE who have been monitored over several months and years. This combination of European cohort databases will increase the chances of identifying discriminating clinical, biological and morphological biomarkers for risk prediction. The identified and selected biomarkers will then be incorporated into the risk prediction tool, which will be validated in the ETHER cluster study of the MORPHEUS programme.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with MVTE who participated in one of the 14 French or European cohorts
Key inclusion criteria (1 listed)
- Cohorts led by members of the European MORPHEUS project consortium European MORPHEUS project
Key exclusion criteria (1 listed)
- Lack of consent in cohorts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consistency between merged data and initial data from each cohort
Time frame: Processing of data from the fourth quarter of 2024 to the third quarter of 2025.
The primary outcome is the consistency between the merged dataset and the original data from each cohort, assessed by comparing key variables across sources to ensure data integrity and accuracy. Consistency will be defined as the absence of significant discrepancies in predefined variables, such as demographic characteristics, baseline measures, and primary endpoints.
3 secondary outcomes
Risk of thromboembolic recurrence
Time frame: 20 YEARS
Risk of hemorrhagic complications
Time frame: 20 YEARS
Risk of death
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 9 Jan 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by University Hospital, Brest at 1 site 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 1 inclusion and 1 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 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (298347348 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?
Consistency between merged data and initial data from each cohort (time frame: Processing of data from the fourth quarter of 2024 to the third quarter of 2025.). 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 9 Jan 2026.