Prospective Sample Collection for Cancer of Bladder

NCT ID: NCT03973671

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-29
• Study Completion Date: 2032-05-31

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.

Conditions

Urinary Bladder Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Joniau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Frank Van Der Aa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Murat Akand, MD

Role: CONTACT

murat.akand@uzleuven.be

+3216346687

Tim Muilwijk, MD

Role: CONTACT

tim.muilwijk@uzleuven.be

+3216346104

Facility Contacts

Murat Akand, MD

Role: primary

murat.akand@uzleuven.be

+3216346687

Other Identifiers

S55725

Identifier Type: -

Identifier Source: org_study_id