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Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)

RecruitingObservational study

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

Official record on ClinicalTrials.gov — NCT05825950

Locations in the U.S.

TexasUniversity 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.