CoMbination of Data From European Cohorts as Part of the European MORPHEUS Project [HORIZON-HLTH-2022-11-01] - "MC-MORPHEUS".
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Venous Thromboembolism. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- Risk of thromboembolic recurrence [Time frame: 20 YEARS]
- Risk of hemorrhagic complications [Time frame: 20 YEARS]
- Risk of death [Time frame: 20 YEARS]
Eligibility criteria
Inclusion criteria
- Cohorts led by members of the European MORPHEUS project consortium European MORPHEUS project
Exclusion criteria
- Lack of consent in cohorts
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chu Brest — Brest
Identifiers
NCT: NCT07328152 · 29BRC24.0090 - MC-MORPHEUS