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Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)
Predicting Outcomes in Intermediate and High-risk Non-muscle Invasive Bladder Cancer Using Automated Analysis of Digital Pathology Data
Who can join
Ages 18 to 99 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Inadequate tissue from TURBT * ≥ T2 bladder cancer * Systemic therapy * Inability to read or write English or Spanish * Unwilling to sign written informed consent
About the study
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.
Sponsor: University of Texas Southwestern Medical Center · Participants: 600 · Started: Jan 25, 2024
Contact the study team
- Jacob Taylor, MD · Phone: 214-645-8791
- Sonobia Garrett · Phone: 2146458482
Official record on ClinicalTrials.gov — NCT05825950
Locations in the U.S.
| Texas | University of Texas Southwestern Medical Center, Dallas University of Texas Health Science Center at San Antonio, San Antonio |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.