Prospective Sample Collection for Cancer of Bladder (ProCaB)

Flemish Prospective Clinical and Pathological Database for Urothelial Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Urinary Bladder Neoplasms

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Murat Akand, MD; Phone Number: +3216346687; Email: murat.akand@uzleuven.be
• Study Contact Backup: Name: Tim Muilwijk, MD; Phone Number: +3216346104; Email: tim.muilwijk@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • University Hospitals Leuven
      • Contact: Murat Akand, MD; Phone Number: +3216346687; Email: murat.akand@uzleuven.be
      • Principal Investigator: Steven Joniau, MD, PhD
      • Principal Investigator: Frank Van Der Aa, MD, PhD
      • Sub-Investigator: Murat Akand, MD
      • Sub-Investigator: Tim Muilwijk, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients treated at University Hospitals Leuven for urothelial cancer that fit the aforementioned inclusion and exclusion criteria.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

UC patients; Patients diagnosed with primary or recurrent non-muscle-invasive bladder (NMIBC) cancer. No experimental intervention will be administered. NMIBC patients will be diagnosed, treated and followed up according to guidelines-based institutional routines. The clinical (demographic, operative and follow-up) and pathological data of the patients will be collected in a complete anonymous way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression to MIBC	Histopathologically proven muscle-invasive bladder cancer (at least T2 disease) in pathological evaluation of the TURBT specimen	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of NMIBC	Clinically (cystoscopically and/or radiologically) proven re-occurence of non-muscle-invasive bladder cancer (Tis, Ta or T1 disease)	5 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven
• Investigators: Principal Investigator: Steven Joniau, MD, PhD, Assistant Professor; Principal Investigator: Frank Van Der Aa, MD, PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2032

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Progression; Recurrence; Risk stratification; Non-muscle-invasive bladder cancer; Muscle-invasive bladder cancer
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: S55725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No