CoMbination of Data From European Cohorts as Part of the European MORPHEUS Project [HORIZON-HLTH-2022-11-01] - MC-MORPHEUS.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07328152

Acronym

MC-MORPHEUS

Enrollment

20000

Registered

2026-01-09

Start date

2024-05-01

Completion date

2029-12-30

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

Venous Thromboembolism, pulmonary embolism, Anticoagulant, deep vein thrombosis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Cohorts led by members of the European MORPHEUS project consortium European MORPHEUS project

Exclusion criteria

* Lack of consent in cohorts

Design outcomes

Primary

Measure	Time frame	Description
Consistency between merged data and initial data from each cohort	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.

Secondary

Measure	Time frame
Risk of thromboembolic recurrence	20 YEARS
Risk of hemorrhagic complications	20 YEARS
Risk of death	20 YEARS

Countries

France

Contacts

Primary ContactFrancis COUTURAUD

francis.couturaud@chu-brest.fr298347348

Backup ContactCécile TROMEUR

cecile.tromeur@chu-brest.fr0298347348

Outcome results