NCT03973671

Prospective Sample Collection for Cancer of Bladder

Flemish Prospective Clinical and Pathological Database for Urothelial Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of the Flemish Databank for Urothelial Cancer is to collect clinical and pathological data of patients treated for urothelial cancer (UC).

Detailed description

The goal of this study is to enable the prospective collection of demographic, clinical, pathological and follow-up data of UC patients after signing informed consent. The specific usage of these prospectively collected clinical data will be described in future trials. Templates for data collection, which also include clinical outcome parameters and quality indicators, were developed in InfoPath™ as an electronic case report form (eCRF) and were implemented within our hospital's electronic patient file system (called Klinisch Werkstation (KWS), which runs in different Flemish hospitals). These eCRFs have been developed based on the recommendations of the European Association of Urology (EAU) guidelines and the Canadian Urological Association (CUA) white paper. Three separate eCRFs were developed for the management of non-muscle-invasive bladder cancer (NMIBC) patients: surgery report, bladder instillation form, and multidisciplinary team (MDT) form. With the scientific output parameters and quality indicators based on the current knowledge, patient flow-charts for the diagnosis of bladder cancer, and management of low-, intermediate- and high-risk NMIBCs have been developed. This databank will be first used to externally validate the European Organization for Research and Treatment of Cancer (EORTC) and the Club Urologico Español de Tratamiento Oncologico (CUETO) nomograms for recurrence and progression in patients with NMIBC who have been treated according to the state of the art and prospectively followed up. In-depth analysis of the data generated in this registry will give us the opportunity to define improvements in patient follow-up protocol. Moreover, based on this dataset, we aim to develop a risk calculator for disease recurrence and progression, which will be readily available for Flemish hospitals to use.

Conditions

• Urinary Bladder Neoplasms

Timeline

• Start date: 2020-05-29
• Primary completion: 2027-05-01
• Completion: 2032-05-01
• First posted: 2019-06-04
• Last updated: 2024-03-28

Locations

1 site across 1 country: Belgium