Clinical trial · Observational
Machine Learning-Based Prediction of BCG Response in High-Risk Non-Muscle Invasive Bladder Cancer Patients
NCT05332353CI-TRIAL-00057874unknownClinicalTrials.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)
This prospective study aims at using Artificial intelligence to create a helpful unbiased machine learning-based model that predicts BCG unresponsiveness in high risk BCG-naïve NMIBC patients incorporating all potential clinico-pathological, radiological and/or molecular prognostic factors.
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 |
|---|---|---|---|
| Non-Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacillus Calmette-Guerin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- BCG responders
- description
- Non-muscle invasive bladder cancer patients who do not have T1/Ta HG recurrence within 6 months of adequate BCG therapy.
- interventionNames
- Drug: Bacillus Calmette-Guerin
- label
- BCG non-responders
- description
- Non-muscle invasive bladder cancer patients who have T1/Ta HG recurrence within 6 months of adequate BCG therapy or CIS within 12 months of BCG therapy
- interventionNames
- Drug: Bacillus Calmette-Guerin
Primary outcomes (1)
- measure
- BCG unresponsiveness
- timeFrame
- 6 months
- description
- T1/Ta HG recurrence within 6 months of adequate BCG therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to give informed consent. 2. High-risk NMIBC (any patient with high grade Ta or high grade T1 or CIS or recurrent multiple large tumors with low grade Ta/T1) 3. Good performance status (Defined as: performance status 0 or 1 at the time of TURBT according to Eastern Cooperative Oncology Group-ECOG-). 4. No prior history of BCG intravesical therapy. Exclusion Criteria: 1. History of previous radiotherapy or systemic chemotherapy. 2. Post TURBT histopathology report showing any of the following; 1. Benign histopathology. 2. Muscle invasive urothelial carcinoma. 3. Non urothelial carcinoma of the bladder.
References
Publications (0)
Data not yet available
No reference posted for this study.