Actively Recruiting
AI-Based Tool to Predict Treatment Response and Recurrence in Intermediate and High-Risk Non-Muscle Invasive Bladder Cancer
Led by University of Texas Southwestern Medical Center · Updated on 2025-08-17
600
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating an Artificial Intelligence AI tool designed to analyze bladder tumor tissue samples to predict how patients with intermediate and high-risk non-muscle invasive bladder cancer NMIBC will respond to intravesical Bacillus Calmette-Gurin BCG and intravesical chemotherapy treatments. This study aims to provide clinicians with a way to identify patients likely to benefit from these therapies or who may need alternative treatments, such as clinical trials or surgery. The study focuses on developing and validating this AI-based histologic analysis tool to improve treatment decisions for NMIBC patients. The study analyzes tissue specimens obtained from transurethral resection of bladder tumor TURBT before BCG induction and at recurrence after BCG treatment. Participants are grouped into high-risk and intermediate-risk NMIBC categories based on criteria like tumor grade, size, recurrence, and presence of carcinoma in situ. The AI tool will be developed and validated using these histologic samples to predict cancer recurrence following intravesical chemotherapy or BCG. This observational study includes patients who have received intravesical therapy such as BCG, mitomycin C, or GemcitabineDocetaxel within six months before enrollment. Participants will have their medical records and pathology samples reviewed to assess tumor characteristics and treatment responses. Researchers will monitor recurrence-free survival at 3, 6, 12, and 24 months after TURBT in both risk groups, as well as progression-free survival at 12 and 24 months. The study involves ongoing observation to evaluate the tools ability to predict outcomes using digital pathology data. Participants will provide informed consent and are followed over time to collect data on their cancer status and treatment results.
CONDITIONS
Brief Title
Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)
Research Team
J
Jacob Taylor, MD
S
Sonobia Garrett
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