Clinical trial · Interventional
Observation Versus Immediate Surgery of Low Risk Bladder Cancer
NCT02700724CI-TRIAL-00034312terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor enrollment
Summary
Brief summary (as posted)
This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immediate Surgery | Other | — | UNRESOLVED |
| Observation | Other | — | UNRESOLVED |
| Surveillance Cystoscopy and Urinary Cytology | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Observation
- description
- Patients will not undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Surgery will commence after 12 months of observation or sooner if cystoscopic evidence of disease progression or patient desire.
- interventionNames
- Other: Observation
- Procedure: Surveillance Cystoscopy and Urinary Cytology
- type
- OTHER
- label
- Immediate Surgery
- description
- Patients will undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Repeated surgery will be offered for additional recurrences.
- interventionNames
- Other: Immediate Surgery
- Procedure: Surveillance Cystoscopy and Urinary Cytology
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * History of low grade, noninvasive urothelial carcinoma of the bladder with a new recurrence that meets the following criteria: * total tumor burden ≤3cm in size (multiple lesions permitted) * low grade appearance (grade 1 or grade 2) * noninvasive appearance (Ta) * no history of carcinoma in situ (CIS) or lesions concerning for CIS * negative urine cytology (atypical or suspicious for low grade neoplasm are acceptable) Exclusion Criteria: * High grade and/or invasive and/or carcinoma in situ disease * Concomitant upper tract urothelial carcinoma * Any patient who is pregnant or who may have plans to become pregnant. * Positive cytology
References
Publications (0)
Data not yet available
No reference posted for this study.