Clinical trial · Observational
Prospective Collection of Samples for Urothelial Cancer of Bladder
NCT04167332CI-TRIAL-00041685ProCSUCaBnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ProCSUCaB (Prospective Collection of Samples for Urothelial Cancer of Bladder) is a monocentric, non-interventional, prospective registry that will recruit newly diagnosed intermediate- and high-risk NMIBC patients in a tertiary center in Flanders.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- NMIBC
- description
- Patients diagnosed with primary 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, and biosamples (blood, urine, bladder cancer tissue) of the patients will be collected in a completely anonymous way.
Primary outcomes (3)
- measure
- Comprehensive multi-layered molecular characterization
- timeFrame
- In two years after completion of recruitment of planned number of patients
- description
- Comprehensive multi-layered molecular characterization of intermediate- and high-risk NMIBC patients at the genomics, epigenomics, transcriptomics, proteomics, lipidomics, metabolomics, and immunohistopathology levels for disease recurrence and progression
- measure
- Multi-biomarker panel for disease recurrence and progression
- timeFrame
- In two years after completion of recruitment of planned number of patients
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. A signal of clinical diagnosis of bladder cancer (symptoms and/or imaging) 2. Giving informed consent to collect clinical data and biological materials prior to surgery 3. An approved pathological diagnosis of transitional cell carcinoma (TCC), with allowance of any variant histopathological subtype 4. An approved pathological diagnosis of non-muscle-invasive bladder cancer (NMIBC), with stages of carcinoma in situ (CIS), Ta (mucosa-confined) and T1 (submucosa infiltrating) Exclusion Criteria: 1. Aged less than 18 years 2. Not giving or withdrawing informed consent 3. Tumor histopathological type other than TCC, such as adenocarcinoma, squamous cell carcinoma
References
Publications (2)
- DERIVEDAkand M, Veys R, Ost D, Vander Eeckt K, Baekelandt F, Van Reusel R, Mattelaer P, Baekelandt L, Van Cleynenbreugel B, Joniau S, Van der Aa F. Cohort Profile: VZNKUL-NMIBC Quality Indicators Program: A Flemish Prospective Cohort to Evaluate the Quality Indicators in the Treatment of Non-Muscle-Invasive Bladder Cancer. Cancers (Basel). 2024 Oct 29;16(21):3653. doi: 10.3390/cancers16213653. PMID 39518090
- DERIVEDAkand M, Muilwijk T, Van Cleynenbreugel B, Gevaert T, Joniau S, Van der Aa F. Prototol for the Prospective Sample Collection for Cancer of Bladder (ProCaB) Trial by the Cancer of the Bladder Leuven (CaBLe) Consortium. Eur Urol Open Sci. 2024 Oct 15;70:21-27. doi: 10.1016/j.euros.2024.09.006. eCollection 2024 Dec. PMID 39483518