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AI Tool Reads Bladder Tumor Slides to Predict Treatment Response

Tests an AI tool that reads tumor slides to predict bladder cancer treatment response.

Plain-language title generated from the registry record
Registry title: Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)

Key facts

Where
Dallas and San Antonio, United StatesSee the 2 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with intermediate or high-risk non-muscle invasive bladder cancer who had bladder treatment (BCG, mitomycin C, or Gemcitabine/Docetaxel) within the last 6 months.

Age
18 years and older (up to 99 years)
Sex
All sexes can join
Disease stage
Intermediate or high-risk non-muscle invasive bladder cancer, confirmed on tissue taken during TURBT
Earlier treatment
Must have had bladder treatment (intravesical BCG, mitomycin C, or Gemcitabine/Docetaxel) within 6 months of joining. Systemic therapy is not allowed.

Main reasons for not taking part

  • Not enough tissue from TURBT
  • Bladder cancer at stage T2 or higher
  • Systemic therapy
  • Cannot read or write English or Spanish
  • Unwilling to sign written informed consent

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 99 years old?

Source: NCT05825950, who can take part

Where in United States

  • University of Texas Southwestern Medical CenterDallas, United StatesTaking people
  • University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
University of Texas Southwestern Medical Center
Trial code
NCT05825950
Record updated
24 August 2026
Original description
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.Read full original descriptionShow less

Predicting Outcomes in Intermediate and High-risk Non-muscle Invasive Bladder Cancer Using Automated Analysis of Digital Pathology Data

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.

Inclusion: 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: Systemic therapy; ≥ T2 bladder cancer; Inadequate tissue from TURBT; Inability to read or write English or Spanish; Unwilling to sign written informed consent.

ClinicalTrials.gov NCT05825950