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Flemish Databank for Urothelial Cancer
| Condition or disease |
|---|
| Urinary Bladder Neoplasms |
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 |
| Estimated Enrollment : | 5000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Flemish Prospective Clinical and Pathological Database for Urothelial Cancer |
| Actual Study Start Date : | August 2013 |
| Estimated Primary Completion Date : | March 2024 |
| Estimated Study Completion Date : | March 2029 |
| 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. |
- Progression to MIBC [ Time Frame: 10 years ]Histopathologically proven muscle-invasive bladder cancer (at least T2 disease) in pathological evaluation of the TURBT specimen
- Recurrence of NMIBC [ Time Frame: 5 years ]Clinically (cystoscopically and/or radiologically) proven re-occurence of non-muscle-invasive bladder cancer (Tis, Ta or T1 disease)
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
| Contact: Murat Akand, MD | +3216346687 | murat.akand@uzleuven.be | |
| Contact: Tim Muilwijk, MD | +3216346104 | tim.muilwijk@uzleuven.be |
| Belgium | |
| University Hospitals Leuven | Recruiting |
| Leuven, Vlaams-Brabant, Belgium, 3000 | |
| Contact: Murat Akand, MD +3216346687 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 | |
| Principal Investigator: | Steven Joniau, MD, PhD | Assistant Professor | |
| Principal Investigator: | Frank Van Der Aa, MD, PhD | Assistant Professor |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 3, 2019 | ||||||||
| First Posted Date | June 4, 2019 | ||||||||
| Last Update Posted Date | November 19, 2019 | ||||||||
| Actual Study Start Date | August 2013 | ||||||||
| Estimated Primary Completion Date | March 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Progression to MIBC [ Time Frame: 10 years ] Histopathologically proven muscle-invasive bladder cancer (at least T2 disease) in pathological evaluation of the TURBT specimen
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
Recurrence of NMIBC [ Time Frame: 5 years ] Clinically (cystoscopically and/or radiologically) proven re-occurence of non-muscle-invasive bladder cancer (Tis, Ta or T1 disease)
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Flemish Databank for Urothelial Cancer | ||||||||
| Official Title | Flemish Prospective Clinical and Pathological Database for Urothelial Cancer | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients treated at University Hospitals Leuven for urothelial cancer that fit the aforementioned inclusion and exclusion criteria. | ||||||||
| Condition | Urinary Bladder Neoplasms | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | 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. |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
5000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | March 2029 | ||||||||
| Estimated Primary Completion Date | March 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Belgium | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03973671 | ||||||||
| Other Study ID Numbers | S55725 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Universitaire Ziekenhuizen Leuven | ||||||||
| Study Sponsor | Universitaire Ziekenhuizen Leuven | ||||||||
| Collaborators | KU Leuven | ||||||||
| Investigators |
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| PRS Account | Universitaire Ziekenhuizen Leuven | ||||||||
| Verification Date | February 2019 | ||||||||
