Access and validation

Governance details

Documents or webpages that describe the overall governance of the data source and processes and procedures for data capture and management, data quality check and validation results (governing data access or utilisation for research purposes).

REGISTRY-GOVERNANCE.pdf

English (260.41 KB - PDF) View document
https://cdn.prod.website-files.com/678e61688455d6c62fc215f8/67b58e3ea021586081deb936_(18)%20REGISTRY-GOVERNANCE.pdf

Biospecimen access

Are biospecimens available in the data source (e.g., tissue samples)?

No

Access to subject details

Can individual patients/practitioners/practices included in the data source be contacted?

No

Description of data collection

The EHE tumors collected must meet the following inclusion criteria:
- New patients managed by the contributing centers with a pathological EHE diagnosis performed or
verified by an expert sarcoma pathologist starting from 1 December 2023 onwards and to be
performed within 6 months from the registration
- Molecular confirmation of the diagnosis (WWTR1::CAMTA1 or YAP1::TFE3)
- Adult patients (aged ≥ 18 years)
The registry started the data collection in 2023.
Data will be prospectively collected on patient characteristics (e.g., information on patient demographics, medical history, health status, etc.), exposure data (e.g., the disease, devices, procedures, treatments or services of interest and outcome data (e.g. survival, progression, progression-free survival, death, etc.).
In addition, data on potential confounders will also be collected.
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis
Start of treatment

Event triggering de-registration of a person in the data source

Death

Event triggering creation of a record in the data source

Specialist encounter
Data source linkage

Linkage

Is the data source described created by the linkage of other data sources (prelinked data source) and/or can the data source be linked to other data source on an ad-hoc basis?

No
Data management specifications that apply for the data source

Data source refresh

Every 6 months

Informed consent for use of data for research

Required for general use

Possibility of data validation

Can validity of the data in the data source be verified (e.g., access to original medical charts)?

Yes

Data source preservation

Are records preserved in the data source indefinitely?

Yes

Approval for publication

Is an approval needed for publishing the results of a study using the data source?

Yes

Data source last refresh

Common Data Model (CDM) mapping

CDM mapping

Has the data source been converted (ETL-ed) to a common data model?

No