Clinical trial · Interventional
Bladder Tumor Biopsy Study to Improve Preoperative Determination of Stage and Grade
A Prospective Study To Assess Whether A Preoperative Tumor Biopsy Can Improve Upon The Endoscopic Impression Determination Of Stage And Grade In Non-Muscle-Invasive Urothelial Carcinoma Of The Bladder
NCT02992990CI-TRIAL-00056026unknownN/AClinicalTrials.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)
To assess whether the addition of a bladder tumor biopsy improves the level of agreement between the pretreatment endoscopic impression and the final postoperative pathology determination of stage and grade in non-muscle-invasive urothelial carcinoma of the bladder.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bladder tumor biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Bladder tumor biopsy
- description
- All subjects will undergo a bladder tumor biopsy followed by transurethral resection.
- interventionNames
- Procedure: Bladder tumor biopsy
Primary outcomes (1)
- measure
- Improvement of the kappa agreement score between preoperative and postoperative assessment of stage and grade in non-muscle-invasive bladder tumors.
- timeFrame
- 3 years
- description
- Assessment of grade, which is the main endpoint will be dichotomous defining lesions between low versus high grade. Stage classification of non-muscle-invasive papillary lesions is also dichotomous between Ta and T1 lesions. CIS can be annotated, but since these are flat, diffuse and non "resectable" in the bladder, they are not part of our main analysis, endpoints, or sample size calculations. The only exception is when the presence of CIS is used to determine grade (high-grade lesion).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Male or females, age 21 or older; * Clinical evidence of urothelial carcinoma of the bladder; * Clinically (endoscopic, by physical examination, and/or axial-imaging) deemed non-muscle-invasive tumor of the bladder (cTis-Ta-T1), of any grade, single or multiple, at initial occurrence or recurrent with \>12 months interval free of disease; * Surgically eligible for the TUR; * Patient or authorized proxy needs to have signed the informed consent form. Exclusion Criteria: * History of any muscle-invasive or non-organ confined bladder tumors (T2 or higher); * Patients with sessile appearing bladder tumors, which may be T2 or higher stage; * Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract; * Concurrent use of anticoagulation medication or chronic use of NSAIDs, including aspirin (other than cardio protective doses of 80mg daily) that has not been appropriately interrupted before the office cystoscopic evaluation; * Patient deemed medically or psychologically unfit for the surgical procedure; * Subject has received any investigational medication within 30 days prior to the registration or is scheduled to receive an investigational drug during the course of the study; Women Exclusion * Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.