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
The purpose of this research study is to learn more about rectal cancer and how the disease and treatment with dostarlimab affect individuals in their daily lives. Study staff will collect relevant clinical information from patient's medical records and enter it into a secure online database. This information will be used to address the following objectives:
• What are the characteristics of patients with rectal cancer who have been treated with dostarlimab?
• What is the real-world clinical response after completing treatment with dostarlimab?
• What is the value of dostarlimab for patients with rectal cancer?
• How is the disease managed during and after treatment with dostarlimab?
Data will be collected from the patient's medical chart from June 2025 to December 2028 and the plan is to recruit 70 patients in Europe, Asia, Australia and South America.
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 data is processed for the purpose of conducting the study.
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
As the Sponsor is a global company, some of their statisticians are located outside the EEA and may have access to the patients’ pseudonymized data outside the EEA. The patient is informed of the possibility that their data may be shared outside the EEA in the ICF. Any international transfer of data is carefully assessed and takes place with appropriate contractual safeguards that ensure the transfer is compliant with the requirements of chapter V GDPR.
Data processed by myTomorrows is exclusively stored and processed within the EEA.
Droits des personnes
The authors confirm that the study data are individual human data (IHD) belonging to GSK and that: The proposed use of the IHD is for study purposes as described in the patient consent form. Use for study purposes means that the use of IHD is consistent with the original study protocol and/or informed consent form in order to meet study objectives, satisfy regulatory requirements, and learn more about the study product and the disease/condition being studied. This includes bringing the product to market or maintaining its access to the market, which involves working with government agencies, insurers or healthcare payers and helping GSK understand the clinical efficacy, safety or efficiency of the product.