Prospective Sample Collection for Cancer of Bladder

Urinary Bladder Neoplasms Clinical Trial

— ProCaB  

Official title:

Flemish Prospective Clinical and Pathological Database for Urothelial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03973671
• Other study ID #: S55725
• Status: Recruiting
• Start date: May 29, 2020
• Est. completion date: May 2032

Study information

• Verified date: March 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Murat Akand, MD
• Phone: +3216346687
• Email: murat.akand[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2032
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression to MIBC	Histopathologically proven muscle-invasive bladder cancer (at least T2 disease) in pathological evaluation of the TURBT specimen	10 years
Secondary	Recurrence of NMIBC	Clinically (cystoscopically and/or radiologically) proven re-occurence of non-muscle-invasive bladder cancer (Tis, Ta or T1 disease)	5 years