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).
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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 database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events. Data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (eDC) tool.

Data imported into the final database are controlled, recoded, and harmonized before import according to the data management plan. All coding procedures are predefined by the data manager. There is no transmission of individual data; all data is centralized within each hospital using a shared anonymous format. All data is exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients.

ESME LC Data Platform aims to be a clinical and therapeutic database centralizing existing and available data from different sources used in the participating hospitals.

Data does not contain any personal data on patients. In compliance with the authorization delivered by the French Data Protection agency to Unicancer, only aggregated statistical reports and publication are released ouside Unicancer.
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

Other

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

patient opposition to data use

Event triggering creation of a record in the data source

patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events.
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?

Yes

Linkage description, pre-linked

SNDS : Système National des données de santé (France) / will be available from second semester 2025.

Linkage description, possible linkage

probabilistic linkage
Data management specifications that apply for the data source

Data source refresh

Yearly

Informed consent for use of data for research

Possibility of data validation

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

No

Data source preservation

Are records preserved in the data source indefinitely?

No

Data source preservation length

20 years years

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