Clinical trial · Interventional
Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder
Assessment of Reliability of Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder at the Time of Radical Cystectomy
NCT02968732CI-TRIAL-00091780active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
A prospective, investigational study to assess the accuracy of standardized cystoscopic evaluation with tissue sampling performed immediately prior to definitive radical cystectomy to predict pathologic tumor stage and identify patients who may benefit from bladder preservation therapy.
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 |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical Cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgical
- interventionNames
- Procedure: Radical Cystectomy
Primary outcomes (1)
- measure
- To evaluate the accuracy of endoscopic assessment in predicting pT0 urothelial disease in the urinary bladder at the time of radical cystectomy.
- timeFrame
- 30 days post surgery
- description
- Endoscopic assessments will be performed using a novel scoring system that allows objective quantification of endoscopic findings at the time of cystoscopy. The findings will be compared to final pathological specimen to determine reliability of predicting pTO disease from endoscopic assessment
Secondary outcomes (3)
- measure
- To determine if genomic tumor signatures from pre-treatment tumor tissue can predict chemotherapy response.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients age \>18 years at the time of consent. 2. Patients with a diagnosis of urothelial carcinoma clinical stage T1-T4NanyM0. 3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 4. Patients must have a clinical decision to proceed with radical cystectomy by any conventional approach (open, laparoscopic, robot-assisted laparoscopic). Time from decision to surgery is usually 3-8 weeks for those who do not receive neoadjuvant chemotherapy and 10-14 weeks for those who receive neo-adjuvant chemotherapy treatment. During this time, eligibility for study participation will be verified. 5. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document or a legally authorized representative who has the ability to understand and willingness to sign a written informed consent and HIPAA authorization on behalf of the participant. 6. Women of reproductive potential must have agreed to use an effective contraceptive measure. Exclusion Criteria: 1. Patients who undergo cystectomy with non-curative intent will be excluded. 2. Patients who have undergone any prior pelvic irradiation. 3. Patients who are pregnant or nursing. Radical cystectomy and prolonged general anesthesia would place the fetus at considerable risk of demise. The prolonged recovery and debility of the patient would severely limit the patient's ability to nurse and care for an infant.
References
Publications (1)
- DERIVEDSatyal U, Valentine H, Liu D, Slifker M, Lallas CD, Trabulsi EJ, Bukavina L, Szeto L, Hoffman-Censits JH, Mouw KW, Faltas BM, Grivas P, Ibragimova I, Porten SP, Van Allen EM, Geynisman DM, Parker DC, O'Neill JP, Drevik J, Christianson SS, Ginzburg S, Correa AF, Uzzo RG, Ross EA, Zibelman MR, Ghatalia P, Plimack ER, Kutikov A, Abbosh PH. Urine Biopsy as Dynamic Biomarker to Enhance Clinical Staging of Bladder Cancer in Radical Cystectomy Candidates. JCO Precis Oncol. 2024 Jun;8:e2300362. doi: 10.1200/PO.23.00362. PMID 38865671