VASCERN Registries project update

natasha • July 20, 2021

The VASCERN Registries Project officially launched on May 1st, 2020 and since then much work has been done by our Registry Working Group, the Registry Technical Teams Working Group and all of our members.

As a reminder, our registry project can be viewed as either a unique registry, with the core data elements required for all rare vascular disease patients and the specific disease elements varying for each 5 Rare Disease Working Groups (RDWGs), or 5 different registries for each of the RDWGs with a common core.

Here are the latest developments from the 5 RDWG’s registries:

HHT Registry CIROCO

  • The database is accessible on the internet (it was agreed within the HHT WG that only the minimum dataset would be filled in for the moment at the European level).       
  • The dictionary of variables from the CIROCO database has been translated from French into English.       
  • They are currently working on the FAIR data point with the VASCERN data stewards.       
  • Within HHT HCP Hospices Civils de Lyon, they are working on the authorizations with the CNIL (French data protection authority) and the contracts to be transmitted to each European center to be signed by their clinical research department and the legal department.

HTAD Registry

  • HTAD HCP APHP Hopital Bichat, has already started entering patient data since July 15, 2021
  • The e-CRF (Case Report Form) of the registry programmed on the electronic data capture CLEANWEB will also be available very soon for some European centers.
  • Accounts have been created for other HTAD centers in Europe and now they are awaiting the signature of legal documentation from these centers in order to start entering patient data
  • The database has been declared on ERDRIdor (European Directory of Registries), the data elements have been decided, and the eCRF is funcitonal

MSA Registry – RaDiCo vEDS

  • Implementation of the program (REDCap): database already available on the RADICO local server and accessible through the web
  • The registry address has been exported to the ERDRIdor
  • Encoding of the dataset (Orphanet, HPO, OMIM) is done
  • Definition of the dataset: minimum dataset and vascular Ehlers-Danlos syndrome (vEDS) specific data elements is completed
  • Exporting the registry metadata on the ERDRImdr is completed

PPL Registry

  • PPL registry (using IT platform Castor) is technically ready to start registering patients
  • It has been registered at ERDRI.dor and ERDRI.mdr.
  • PPL HCP Nij Smellinghe hospital has signed the contract with Castor and the installation of Castor is now taking place.
  • PPL HCP Helsinki University Hospital almost ready to register patients: has signed permit for using the hospital data and soon to sign contract with Castor
  • Disease specific elements are defined and are at EJP-RD for selecting and modeling
  • The German PPL HCP, Földiklinik, has also signed the contract with Castor.

VASCA Registry

  • VASCA registry is technically ready to accept patients. With the help of our VASCERN data steward, VASCA HCP Radboud University Medical Center had started registering patients with EUPID (pseudonymisation tool) but as EUPID is no longer used because of security issues these patients have been removed. There is a new pseudonymisation tool being considered as a replacement called SPIDER (Secure Privacy-preserving Identity management in Distributed Environments for Research). This tool is still under development and discussed within the ERN’s. 
  • It has been registered at ERDRI.dor and ERDRI.mdr.
  • VASCA HCP Helsinki University Hospital almost ready to register patients: has signed permit for using the hospital data and soon to sign contract with Castor
  • Disease specific elements are defined and are at EJP-RD for selecting and modeling

In regards to the overall project, the team is currently investigating the setup of a central Fair Data Point for VASCERN which will be the Fair Data Point for HHT and HTAD and to which MSA and VASCA and PPL registries will link.

We look forward to more developments in the fall from the Registry Working Group!

For more information on the VASCERN Registry project, please visit our Registry page, and to meet the team please visit our Registry WG page.

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