Synthetic Generation of Hematological Data Over Federated Computing Frameworks: SCD Use Case

NCT06794281 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-03-12

No results posted yet for this study

Summary

Haematological diseases (HDs) are a large group of disorders resulting from quantitative or qualitative abnormalities of blood cells, lymphoid organs and coagulation factors. Despite most of them (\~74%) are rare, the overall number of HD affected patients worldwide is important, placing a considerable economic burden on healthcare systems and societies. Despite the existence of several collaborative research groups at national and EU level, current clinical approaches are often ineffective, particularly for rarest conditions, due to the relatively low number of patients per disease and the high number of unconnected clinical entities.

SYNTHEMA aims to establish a cross-border data hub where to develop and validate innovative AI-based techniques for clinical data anonymisation and synthetic data generation (SDG), to tackle the scarcity and fragmentation of data and widen the basis for GDPR-compliant research in rare hematological disorders (RHD). The project will focus on one representative RHD use case: sickle-cell disease (SCD).

Conditions

Interventions

OTHER

Generate synthetic multimodal (clinical, omics and imaging) data for rare haematological diseases with a validated clinical result

O1. Provide novel methods and capabilities to generate synthetic multimodal clinical, omics and imaging data for SCD with a validated clinical result. O2. Develop de-identification, minimisation and anonymisation pipelines, including automatic assessment of privacy levels, at the service of clinical research and care. O3. Consolidate and scale-up the use of FL applications, SMPC and DP solutions for privacy-preserving local algorithm training and global model aggregation. O4. Ensure ethical and GDPR compliance in anonymised and synthetic data-driven research in RHDs. O5. Ensure wide uptake and scalability of the developed methodologies and tools through effective stakeholder engagement, dissemination and open science practices.

Sponsors & Collaborators

  • Universidad Politecnica de Madrid

    collaborator OTHER
  • Datawizard SRL

    collaborator UNKNOWN
  • University of Southampton

    collaborator OTHER
  • Humanitas Mirasole SpA

    collaborator OTHER
  • Charite University, Berlin, Germany

    collaborator OTHER
  • Universita degli Studi di Padova

    collaborator UNKNOWN
  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER
  • Vicomtech

    collaborator UNKNOWN
  • GLSMED Learning Health S.A.

    collaborator OTHER
  • UMC Utrecht

    collaborator OTHER
  • Intrasoft

    collaborator UNKNOWN
  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Italy
  • Netherlands
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794281 on ClinicalTrials.gov