A Real-world Study to Evaluate Clinical Outcomes of dostarlimab in Patients with Previously Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
Objectif(s) de la recherche et intérêt pour la santé publique
Finalité de l'étude
Objectifs poursuivis
Domaines médicaux investigués
Bénéfices attendus
This is a non-interventional study with an aim to describe the characteristics of participants with stage II/III dMMR/MSI-H locally advanced rectal cancer and evaluate the clinical outcomes of dostarlimab treatment in this participant population.
Primary objective: Percentage of participants who maintain real-world complete clinical response (rw-cCR) for 12 months.
Time frame: Index date (first disease response assessment following end of dostarlimab treatment) up to 12 months.
Données utilisées
Catégories de données utilisées
Source de données utilisées
Autre(s) source(s) de donnée(s) mobilisée(s)
Appariement entre les sources de données mobilisées
Variables sensibles utilisées
Justification du recours à cette(ces) variable(s) sensible(s)
The proposed use of the IHD is Study Use* as outlined in the patient information leaflet.
* Study Use means - the use of IHD is as stated in the original study protocol and/or aligned with the informed consent form to answer the study objectives and satisfy regulatory requirements and learn more about the product studied and the disease/condition studied. This includes bringing the product to market or maintaining market access which includes working with government agencies, insurers or health care payers and aiding GSK’s understanding of clinical efficacy, safety, or effectiveness of the product.
Recours au numéro d'identification des professionnels de santé
Plateforme utilisée pour l'analyse des données
Acteurs finançant et participant à l'étude
Responsable(s) de traitement
Type de responsable de traitement 1
Responsable de traitement 1
Localisation du responsable de traitement 1
Représentant du responsable de traitement 1
Responsable(s) de mise en oeuvre non cités comme responsable de traitement
Responsable de mise en oeuvre non cité comme responsable de traitement 1
Calendrier du projet
Base légale pour accéder aux données
Encadrement réglementaire
Durée de conservation aux fins du projet (en années)
15
Existence d'une prise de décision automatisée
Fondement juridique
Article 6 du RGPD (Licéité du traitement)
Article 9 du RGPD (Exception permettant de traiter des données de santé)
Transfert de données personnelles vers un pays hors UE
GSK is committed to exercising high standards of integrity in dealing with personal information and has adopted Binding Corporate Rules (BCRs) to enable them to make international transfers of personal information, within their group of companies, in compliance with data protection laws of the European Union and the United Kingdom, in particular the General Data Protection Regulation (Regulation 2016/679) (GDPR) and its equivalent in the United Kingdom. https://www.gsk.com/media/vldjkkst/binding-corporate-rules-policy.pdf
Data processed by the CRO is exclusively stored and processed within the EEA.
Droits des personnes
An information sheet (consent form) will be given to all patients. It explains that, at any time, the patient have the following rights regarding their personal data:
- Access to their data
- Rectification of inaccurate or incomplete data
- Erasure of their data
- Data portability, allowing transfer of their data to a third party
- To object to the processing of their data
Additionally, the information sheet (consent form) provides clear instructions on how to submit such requests.
The information sheet (consent form) also provides details about the French Data Protection Authority (DPA), the CNIL, including their contact information and instructions on how to file a complaint.