Clinical trial NCT03973671: Prospective Sample Collection for Cancer of Bladder
Official title: Flemish Prospective Clinical and Pathological Database for Urothelial Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Bladder Neoplasms
Keywords: Risk stratification
Recurrence
Progression
Non-muscle-invasive bladder cancer
Muscle-invasive bladder cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2019-06-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated at University Hospitals Leuven for urothelial cancer that fit the aforementioned inclusion and exclusion criteria.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* who are aged between 18-90,
* who are of male or female sex,
* who give their informed consent to collect their clinical and pathological data,
* who are planned to undergo TURBT for BC,
* who are planned to undergo (salvage) radical cystectomy with or without an extended pelvic lymph node dissection,
* who are planned to undergo tumor biopsy (from primary or metastatic tumor),
* who are planned to undergo radical nephroureterectomy ± partial cystectomy or segmental ureterectomy, with or without a lymph node dissection,
* who are planned to undergo endoscopic tumor biopsy or resection,
* from whom metastases will be surgically removed.

Exclusion Criteria:

* patients who do not give their informed consent to collect their clinical and pathological data,
* patients who withdraw their informed consent to use their clinical and pathological data,
* patients who refuse the planned treatment,
* women who are pregnant or have suspicion of pregnancy.

Primary outcomes:
measure: Progression to MIBC
timeFrame: 10 years
Secondary outcomes:
measure: Recurrence of NMIBC
timeFrame: 5 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Assistant Professor
name: Steven Joniau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor
name: Frank Van Der Aa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: