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NCT Number: NCT07328152

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

Combine clinical, biological and morphological data from 14 French and European cohorts into a single database.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lack of consent in cohorts

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Risk of thromboembolic recurrence

    Time frame: 20 YEARS

  2. Risk of hemorrhagic complications

    Time frame: 20 YEARS

  3. Risk of death

    Time frame: 20 YEARS

Study contacts

Contact information is provided by the study sponsor or research team.

Cécile TROMEUR

CONTACT

[email protected]

0298347348 ext. +33

Francis COUTURAUD

CONTACT

[email protected]

298347348 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: MC-MORPHEUS

Important dates

Study start
2024
Primary completion
2024
Study completion
2029
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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