RHINE: A retrospective study assessing real-world treatments and outcomes of high risk NMIBC and MIBC patients in England, Europe, and Canada
Objectif(s) de la recherche et intérêt pour la santé publique
Finalité de l'étude
Objectifs poursuivis
Domaines médicaux investigués
Bénéfices attendus
Background:
Bladder cancer is the 9th most common cancer globally, with high incidence in Spain, Germany, and Italy. It includes three types:
Non-muscle invasive bladder cancer (NMIBC) – ~75% of cases
Muscle invasive bladder cancer (MIBC) – ~20–25% of cases
Metastatic urothelial cancer (mUC) – <5% of de novo cases
Despite existing research, outcomes vary widely across subgroups and regions. There's limited international data, especially from Europe and Canada.
Purpose:
To address the knowledge gaps in the effectiveness of treatment regimens used in the real world by analyzing treatment patterns and outcomes in bladder cancer patients across six countries: Canada, England, France, Germany, Italy, and Spain.
Objectives
Primary: Describe treatment patterns in hr-NMIBC and MIBC patients prior to recurrence or progression
Secondary:
- Describe treatment patterns among MIBC patients by eligibility for cisplatin-based chemotherapy prior to recurrence or progression
- Describe demographics and clinical characteristics of patients with hr-NMIBC and MIBC overall, and by eligibility for cisplatin-based chemotherapy
- Assess clinical outcomes (Overall survival, cancer-specific survival, disease-free survival, event-free survival, and pathological complete response) in patients with hr-NMIBC and MIBC overall, and by eligibility for cisplatin-based chemotherapy
Exploratory:
- Describe specialties seen, and where possible, referral patterns of patients with hr-NMIBC and MIBC overall, and by eligibility for cisplatin-based chemotherapy prior to recurrence or progression
- Describe direct medical costs of NMIBC/MIBC in patients with hr-NMIBC and MIBC overall, and by eligibility for cisplatin-based chemotherapy prior to recurrence or progression
- Describe NMIBC/MIBC-related HCRU in patients with hr-NMIBC and MIBC overall, and by eligibility for cisplatin-based chemotherapy prior to recurrence or progression
Methods
Design:
Retrospective cohort study using pseudonymized/anonymized patient-level data from:
- CAS (Cancer Analysis Service) in England
- OEN (Oncology Evidence Network) in Europe and Canada
Study Periods:
- CAS: 2012–2023 (patients identified 2015–2022)
- OEN: 2015–2023 (patients identified 2018–2022)
Population:
- Cohort 1: hr-NMIBC patients who received TURBT
- Cohort 2: MIBC patients, split into:
- Sub-cohort 2a: MIBC patients ineligible for cisplatin-based chemotherapy
- Sub-cohort 2b: MIBC patients eligible for cisplatin-based chemotherapy
Outcomes:
- Descriptive analysis of treatment patterns, demographic and clinical characteristics, setting of care, clinical outcomes (Overall survival, disease free survival, event free survival, cancer specific survival and pathological complete response), healthcare resource utilization and direct medical costs and referral patterns
Sample Size:
- CAS: ~27,000 patients (~17,000 hr-NMIBC; ~10,000 MIBC)
- OEN: ~1,000 patients (~300 hr-NMIBC; ~700 MIBC))
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)
Data required to address the objectives of the study, specifically, demographics, clinical outcomes and healthcare resource utilization
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
Calendrier du projet
Base légale pour accéder aux données
Encadrement réglementaire
Durée de conservation aux fins du projet (en années)
2
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
The data contained in the electronic medical record (EMR) will be transferred from the center to IQVIA via a secure file transfer protocol (SFTP).
The data will then be downloaded to a secure server environment located in the UK and backed up in Ireland, with restricted access, which complies with the following requirements:
• Your data will be stored on a secure server with limited access, requiring two-factor authentication for access.
• The high-security server is located in a physically segregated facility, equipped with ISO27001 certified security controls, as well as information security policies and procedures.
• All tools and services are hosted within the server's secure enclave; data never leaves the enclave for processing.
• Security and privacy training is mandatory for all employees with server access, and access rights are regularly reviewed and updated.
• All team members complete information security awareness training according to ISO27001, global data privacy, and other IQVIA internal standard operating procedures.
• All user logins and logouts, as well as all data movement within the enclave, are logged.
• Data transfer to and from the enclave occurs exclusively through specific methods (using SFTP) and is carried out by authorized personnel within the server.
Droits des personnes
The study is non interventional, and the analysis is based on secondary data. No participant identifiable data is collected in any of the planned approaches. Thus, ethical review for such a study resulting in the release of anonymous, aggregated data is not required. Investigators will ensure that personal identifiers will be removed from any study files that are accessible to non-study personnel in accordance with applicable laws and regulations. Whenever feasible, study files will be coded and stripped of personal identifiers, and code keys will be stored separate from study files.
In Kaplan-Meier curves, in case the number of a group of patients under study is less than 5, then the entire curve presented for those patients would be suppressed. Furthermore, if after a certain period of time most patients experience the outcome of interest, the Kaplan-Meier curve would be truncated after that period, to avoid showing the curve for a small number of patients. For example, if the number of a group of patients is 15 at the beginning of the follow-up, and more than ten patients experience the event by 1 year, then the Kaplan-Meier curve would be truncated after one year.
Délégué à la protection des données
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