Clinical trial · Interventional
Can We Predict of the Response of High Risk Non Muscle Invasive Bladder Cancer Patients to Intravesical Bacillus Calmette-Guerin? The Role of Immunological Markers
NCT04723121CI-TRIAL-00049592completedN/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)
Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage. Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis | Diagnostic Test | — | UNRESOLVED |
| Urine ELISA for immunological markers (IL-2 and IL-10) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- High risk NMIBC
- description
- Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered
- interventionNames
- Diagnostic Test: Urine ELISA for immunological markers (IL-2 and IL-10)
- Diagnostic Test: Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis
Primary outcomes (3)
- measure
- Initial BCG complete response
- timeFrame
- 3 months
- description
- free cystoscopy/negative cytology at 3 months.
- measure
- Recurrence
- timeFrame
- 1 year
- description
- Recurrence is defined as development of new tumor/positive cytology in patients with ICR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with primary or recurrent NMIBC for whom primary TURBT was done. Exclusion Criteria: 1. Patients with previous BCG instillation, 2. benign pathology 3. Variant histology 4. Non urothelial carcinoma, 5. concommitent upper tract urothelial tumors, detrusor muscle invasion 6. low or intermediate risk NMIBC
References
Publications (0)
Data not yet available
No reference posted for this study.