Status:
UNKNOWN
Machine Learning-Based Prediction of BCG Response in High-Risk Non-Muscle Invasive Bladder Cancer Patients
Lead Sponsor:
Mansoura University
Conditions:
Non-Muscle Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 incorpor...
Detailed Description
Introduction: In the era of BCG shortage and BCG-associated morbidity, the development of prognostic models remains a never-ending topic of research to predict Non Muscle Invasive Bladder Cancer (NMI...
Eligibility Criteria
Inclusion
- Ability to give informed consent.
- 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)
- Good performance status (Defined as: performance status 0 or 1 at the time of TURBT according to Eastern Cooperative Oncology Group-ECOG-).
- No prior history of BCG intravesical therapy.
Exclusion
- History of previous radiotherapy or systemic chemotherapy.
- Post TURBT histopathology report showing any of the following;
- Benign histopathology.
- Muscle invasive urothelial carcinoma.
- Non urothelial carcinoma of the bladder.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05332353
Start Date
April 1 2022
End Date
December 1 2023
Last Update
April 18 2022
Active Locations (1)
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1
Urology and Nephrology Center
Al Mansurah, Outside U.S./Canada, Egypt, 35511