Data access request
Registry design
The Registry is designed to prospectively and retrospectively collect clinical data derived from diagnostic tests and treatments performed by the HCP as part of patient management. The data collected for the Registry will not entail further examinations or admissions to the HCP and/or additional appointments to those normally provided. Medications, procedures, visits and check-ups are prescribed according to standard clinical practice. The only intervention will be to collect health status data, already present in the clinical file.
In other words, it will be an observational, real-world registry
The registry utilizes a hybrid architecture, where data can either be shared in pseudonymized form through the registry coordinator's e-CRF in a centralized model or stored locally at the participating HCP in a federated model (Fig.1).
In the federated model, data are kept at its source thus, no copies of datasets are generated and/or shared with third parties. Data are collected in a pseudo anonymised form locally using a e-CRF shared by the coordinator but locally installed. The Personal Health Train (PHT) enables data from multiple organizations to be analysed without identifiable data leaving the organization. Vantage6 is the open source implementation of the PHT (https://www.vantage6.ai). Vantage6 uses the mathematical principle of “federated learning”, typically applied to horizontally partitioned data (i.e. organizations provide data from different patient cohorts, but with similar characteristics/items). Federated learning is based on the mathematical principle of splitting computations into (a) parts at the station (local HCP or registry) and (b) a central part (https://distributedlearning.ai/).
A EURACAN registry help-desk will be set up to support: installation of the different software at the local level; data integration solutions (e.g. data transfer from an existing DB or data warehouse etc.); and data collection. Each HCP and/or registry should identify an IT person responsible for software installation and related issues (e.g. server, security licences etc.).
The registry will exploit data available from:
- national or regional registries/databases (DBs) dedicated to the rare adult solid cancer of interest;
- HCP registries/DBs;
- ad hoc data collection by HCPs.
If a European registry/DB (e.g. the ENETS Registry) is already available for any of the rare adult solid cancers of interest, formal collaboration will be discussed and finalised.
If a registry or DB exists at national level or at the HCP level, information will be extracted according to the standard format agreed for the EURACAN registry, after checking semantic interoperability. Extracted data will be entered in the DB developed ad hoc for the EURACAN registry.
In the absence of a registry or DB, data will be manually entered in the EURACAN registry’s e-CRF (Case Report Form) on REDCap.
Study Proposal Submission Tool
The tool, developed as a REDCap study, allows research interested in leveraging the federated data registry established by EURACAN, to share their study proposal to the EURACAN board/secretariat/personnel as a simple web-based survey.
The whole approval process, managed by EURACAN personnel, involves, in addition to the applicant, a group of reviewers tasked with evaluating the appropriateness and validity of the study proposal.
In addition to its main functionality of supporting the request for new studies, the tool also includes dynamic dashboards, capable of providing EURACAN staff with comprehensive information on the various ongoing requests and those already evaluated.
European plateform on rare disease registration
EURACAN is working closely with the to on board its Centers on the European Rare Disease Registry Infrastructure - ERDRI. Six Head and Neck centers (San Raffaele hospital, National Center for Oncological Hadrontherapy (CNAO), IRCCS Humanitas Research Hospital, Fondazione IRCCS Istituto Nazionale dei Tumori, Istituto Europeo di Oncologia, IFO Regina Elena National Cancer Institute) have already participated to dedicated training sessions including hands on sessions and have inserted their descriptions and data schemes in the European Directory of Registries - ERDRI.dor and the metadata repository - ERDRI.mdr respectively and have started to use the pseudonymisation tool offered by the EU RD Platform – ERDRI.spider. In addition to its pseudonymisation function, ERDRI.spider makes it possible to identify if one and the same patient was registered in two or more registries (linkage function) and to transfer pseudonymised patient data between registries.
Onboarding ERDRI of more EURACAN centers and dedicated training for the EURACAN centers will continue.