Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)
Recruiting now
Conditions studied: Non-muscle-invasive Bladder Cancer
In brief
This is a multi-center study and the aim is to develop and validate an Artificial Intelligence (AI) -based histologic analysis tool to predict responsiveness to intravesical Bacillus Calmette-Guérin (BCG) and intravesical chemotherapy in intermediate and high-risk non-muscle invasive bladder cancer patients.
Key facts
- Study ID
- NCT05825950
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 600
- Starts
- 2024-01-25
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-08-17
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of intermediate or high-risk non-muscle invasive bladder cancer as defined by AUA/SUO criteria (Intermediate-risk: recurrence within 1 year low grade Ta, solitary low grade Ta >3 cm, multifocal low grade Ta, high grade Ta ≤3 cm, low grade T1; High risk: high grade T1, recurrent high grade Ta, high grade Ta >3 cm, multifocal high grade Ta, any CIS, any BCG failure in high grade disease, any variant histology, any lymphovascular invasion) following pathologic evaluation of tissue specimens from TURBT.
- Intravesical therapy within 6 months from enrollment including patients treated with BCG, mitomycin C, or Gemcitabine/Docetaxel.
- English or Spanish speakers
- ≥ 18 years of age
- Ability to understand and the willingness to provide an informed consent
You may not qualify if…
- Inadequate tissue from TURBT
- ≥ T2 bladder cancer
- Systemic therapy
- Inability to read or write English or Spanish
- Unwilling to sign written informed consent
Where it is running
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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