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

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

Study Overview

• Status: Recruiting
• Conditions: Venous Thromboembolism

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 Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Francis COUTURAUD; Phone Number: +33 298347348; Email: francis.couturaud@chu-brest.fr
• Study Contact Backup: Name: Cécile TROMEUR; Phone Number: +33 0298347348; Email: cecile.tromeur@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHU Brest
    • Contact: Francis COUTURAUD; Phone Number: +00332 98 34 73 47; Email: francis.couturaud@chu-brest.fr
    • Contact: Hélène FORTIN PRUNIER; Email: helene.fortin-prunier@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with MVTE who participated in one of the 14 French or European cohorts

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Lack of consent in cohorts

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Processing of data from the fourth quarter of 2024 to the third quarter of 2025.

Secondary Outcome Measures

Outcome Measure	Time Frame
Risk of thromboembolic recurrence	20 YEARS
Risk of hemorrhagic complications	20 YEARS
Risk of death	20 YEARS

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: December 26, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Venous Thromboembolism; deep vein thrombosis; pulmonary embolism; Anticoagulant
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Thrombosis; Pulmonary Embolism; Venous Thrombosis; Venous Thromboembolism
• Other Study ID Numbers: 29BRC24.0090 - MC-MORPHEUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No