FAQs
The EURACAN registry serves as a macro-database that gathers information on the 10 families of rare cancers. Each family may include one or more specific registries where relevant data are collected through eCRF (electronic case report forms).
Thus, when referring to EURACAN, we are talking about the general data source for rare cancers. However, within this framework, there are sub-registers that have been specifically created to focus on and address particular pathologies (e.g., the EHE Registry, the Sarcoma Registry, and the Head and Neck Registry).
Yes, the documents to be submitted are available on the website. However, it is always advisable to contact the Promoting Center to confirm that the documents have not been updated over time (e.g., the list of participating centers). Other specific documents, such as the DPIA, are shared only by the Promoting Center and are not available on the website.
Not necessarily. For the EHE registry, it is expected that participating centers have at least 1-2 cases per year. For the head and neck or sarcoma registries, ideally, centers should have at least 10 cases annually. In general, the cases should be those diagnosed and treated at the participating center. Second opinions are not considered.
To participate in a registry using the federated data collection approach, the center must join the REDCap consortium for free in order to obtain an institutional REDCap account. The center should also request the Promoting Center to provide the eCRF to upload into their REDCap system. After the IT department uploads the eCRF, the center can begin collecting pseudonymized data, to which the Promoting Center will never have direct access
If the participating center is collecting data using the federated approach—where the eCRF is locally installed in the center's own REDCap system—the center should contact its own REDCap IT support for any eCRF issues. On the other hand, if data collection is done through the centralized approach—using the eCRF from the Promoting Center via a link—the center should contact the Promoting Center
(contact: simone.bonfarnuzzo@istitutotumori.mi.it and melissa.gilsanjines@istitutotumori.mi.it), specifying the relevant registry and the issue encountered.
For the Head and Neck registry and the EHE registry, training videos on eCRF completion are available on the website. It is strongly recommended to always refer to the specific registry codebooks, which provide explanations and guidance on the meaning of the variables.
The database should be updated at least every 3 months to allow for data quality checks to be performed every 6 months.
Data contribution to the registry is open to all authorized healthcare institutions. To become a participating center in one of the EURACAN sub-registers, the center must contact the Promoting Center (Fondazione IRCCS Istituto Nazionale dei Tumori (INT)) to indicate the registry of interest and the number of annual cases they expect to contribute. The Promoting Center will then provide all the necessary documents, which the center must submit to its own Ethics Committee for approval. Additionally, the center must send the DPIA and the accompanying documents shared by the Promoting Center to its DPO/privacy office to evaluate whether to participate in centralized or federated data collection. Once this decision is made, the agreements will be drafted.
No, the contribution from participating centers is entirely voluntary, and no form of compensation is provided for contributing to the database of the various registries.
New centers in the Head and Neck registry can contribute data for all four major sites (nasopharynx, salivary glands, nasal cavities and paranasal sinuses, and middle ear), or focus on the sites they most frequently treat (e.g., only salivary glands).
Regarding the starting year for data contribution, each center can choose the year they prefer, provided it is not earlier than 2018. If the center has a significant number of past cases with easily accessible information, it can contribute with retrospective data. Otherwise, the center may contribute prospectively with patients diagnosed in the year they join the registry.
The center must contact the Promoting Center to obtain the link to the eCRF available on the Promoting Center's institutional REDCap and use it to collect data. With this data collection method, the Promoting Center will have direct access to the pseudonymized data from the contributing center.
Absolutely. Once a center becomes part of a registry, it is free to contact the Promoting Center with any questions regarding the completion of the eCRF, as well as any clinical concerns related to the eCRF or the codebook.
Reported issues will be addressed via email or through teleconferences with the Promoting Center, aiming to make the data entry process easier and improve the accuracy of data collection.
Proposals for additional information will be discussed directly with the Principal Investigator of the registry.
Yes, Vantage6 is required for federated data collection. This involves the installation of a V6 node, which can be set up by the IT department of the new participating center, following an instruction manual provided by the Promoting Center and technical collaborators.
The node must always be online to allow the Promoting Center to perform data quality checks and analysis. If the node goes offline, the Promoting Center will contact the center to have the node reactivated.
The Promoting Center will send an Excel document to each participating center, highlighting inconsistencies, errors, and details that the center must verify and resolve.
To help centers understand how to read the data quality check report, the Promoting Center will organize a training session with the new center, explaining how to interpret the report and addressing any questions or concerns.
Data quality checks will initially be conducted every 6 months, and later annually. The Promoting Center will notify the centers well in advance of the scheduled data quality check days, so that the centers have time to update their data and add new cases.