The DigiONE was a 30-month project (GA 101115081; 11/2023-7/2026), co-funded by the European Commission, under the ERDF Interregional Innovation Investments (I3) Instrument. It brought together 17 leading cancer centres in 9 countries with support from 10 private/SME partners distributed across 19 S3 regions. Developed and coordinated within the DIGICORE ecosystem, the project’s principal objective was to move federated oncology research from concept towards operational and commercial use by establishing a privacy-preserving network capable of generating real-world evidence. This approach was validated through the DigiACT study, which concluded in April 2026 with a pan-cancer federated analysis across key oncology hospitals at different levels of digital maturity, aggregating results from approximately 25,000 oncology patient per year, and ~140k diagnoses across lung, breast, GI, prostate, and other key tumours that can be expanded to new onboarding hospitals and research centers.

The DigiACT study’s primary objective was to assess delay from diagnosis to treatment as a real-world indicator of cancer burden across the federated DigiONE network. Secondary outputs analysed patient demographics and survival-related measures, providing a foundation for cohort characterisation, outcomes assessment and future evidence-generation use cases across the federated network.

Participating hospitals aligned Minimal Essential Description of Cancer (MEDOC) core oncology concepts to the OMOP Common Data Model, and deployed secure local analytics capabilities to enable analyses within the hospital environment. Targeted NLP supported cohort identification and the conversion of key oncology variables captured in free text or non-standardised formats into structured, analysis-ready data. In some nodes, automated data pipelines using the IQVIA Health Data Repository Platform support regular data refresh, while the federated model enabled analytical code to be sent to the data, with only aggregated, non-identifiable results shared across the network. Deployment followed an iterative approach with early adopter hospitals informing refinements to the architecture and processes before broader implementation across all centres with OMOP environments capturing the core oncology dataset.

Results were generated through a coordinated multi-centre collaboration, with outputs stratified by tumour types and regional aggregation, characterising patient cohorts across 13 cancer indications, including breast and lung cancer. The analysis consistently analysed cohort sizes, geographical distribution, and longitudinal vital status at 12, 24 and 36 months. Together, these outputs show that the network can produce comparable, aggregated oncology evidence across multiple hospital systems while preserving local data governance. They also provide an initial view of cohort composition and survival status over time, supporting future analyses of treatment pathways, outcomes and real-world oncology burden.

A Late-Breaking Abstract has been submitted to the ESMO 2026 Congress; if accepted we will present the results, providing an external opportunity to share the study findings with the oncology community.

The DigiACT study established the DigiONE network sites as a scalable, privacy-by-design platform for federated oncology research, with applicability across academic and industry real-world evidence programmes. Building on these completed objectives, the network is now positioned to support an expanded broader evidence-generation portfolio, including disease natural history, cohort characterisation, treatment patterns, treatment sequencing and other high-value oncology research questions. Its federated, collaborative model is designed to extend beyond the initial consortium sites, actively welcoming new institutions to join a growing network, contribute to its evolution and directly benefit from participation in the generation of high-value, multi-centre real-world oncology evidence at scale.