Urinary Bladder NeoplasmsProCaBNCT03973671
Prospective Sample Collection for Cancer of Bladder
An observational study of Urinary Bladder Neoplasms, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urinary Bladder Neoplasms
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 29 May 2020to May 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at University Hospitals Leuven for urothelial cancer that fit the aforementioned inclusion and exclusion criteria.
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Murat Akand, MD, +3216346687, murat.akand@uzleuven.be
Steven Joniau, MD, PhD
About this study
Official title: 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).
Read the 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
- Keywords
- Risk stratification, Recurrence, Progression, Non-muscle-invasive bladder cancer, Muscle-invasive bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence, Disease Progression, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Progression to MIBC
Histopathologically proven muscle-invasive bladder cancer (at least T2 disease) in pathological evaluation of the TURBT specimen
Measured: 10 years
Secondary outcomes (1)
Recurrence of NMIBC
Clinically (cystoscopically and/or radiologically) proven re-occurence of non-muscle-invasive bladder cancer (Tis, Ta or T1 disease)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start29 May 2020
- Primary completionMay 2027 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Steven Joniau, MD, PhD, Principal investigator, Assistant ProfessorFrank Van Der Aa, MD, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973671
- Sponsor's protocol ID
- S55725
- Acronym
- ProCaB
- Status last verified
- Mar 2024
- First submitted
- 3 Jun 2019
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flemish Prospective Clinical and Pathological Database for Urothelial Cancer
- ClinicalTrials.gov ID
- NCT03973671
- Acronym / sponsor ID
- ProCaB / S55725
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- Risk stratification, Recurrence, Progression, Non-muscle-invasive bladder cancer, Muscle-invasive bladder cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 29 May 2020 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at University Hospitals Leuven for urothelial cancer that fit the aforementioned inclusion and exclusion criteria.
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression to MIBC
Time frame: 10 years
Histopathologically proven muscle-invasive bladder cancer (at least T2 disease) in pathological evaluation of the TURBT specimen
1 secondary outcome
Recurrence of NMIBC
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Joniau, MD, PhD principal investigator
Assistant Professor
Frank Van Der Aa, MD, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasms, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Murat Akand, MD (+3216346687, murat.akand@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to MIBC (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.