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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-muscle-invasive Bladder Cancer

Detailed Description

Analysis will be performed on the most recent Transurethral resection of bladder tumor (TURBT) histologic specimen obtained prior to BCG induction and on histologic specimens at time of recurrence after BCG induction. This stratification is of potential utility to clinicians for patient counseling purposes, for the identification of patients likely to benefit from induction or re-induction with BCG, and for consideration of alternative treatment strategies including clinical trials, chemotherapy, or cystectomy. Additionally, there is currently no reliable tool for identifying which NMIBC patients are most likely to benefit from adjuvant BCG versus intravesical chemotherapy. This is of current relevance in the management of Intermediate-risk (IR) NMIBC since both BCG and chemotherapy are first-line treatment options and will likely become of increasing relevance in High-risk (HR) NMIBC as efficacious first-line alternatives to intravesical BCG are introduced into clinical practice. In the proposed prospective study, the study team also aims to develop and then validate an AI-based histologic analysis tool for clinicians that is intended to predict recurrence following intravesical chemotherapy in IR and HR NMIBC patients.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Jacob Taylor, MD; Phone Number: 214-645-8791; Email: Jacob.Taylor@UTSouthwestern.edu
• Study Contact Backup: Name: Sonobia Garrett; Phone Number: 2146458482; Email: Sonobia.Garrett@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9164
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Principal Investigator: Solomon Woldu, MD
      • Contact: Sonobia Garrett; Phone Number: 2146458482; Email: Sonobia.Garrett@UTSouthwestern.edu
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio
      • Principal Investigator: Robert Svatek, MD
      • Contact: Brandi Weaver; Phone Number: 210-567-0178; Email: WeaverB@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects identified in urology clinics after a diagnosis of non-muscle invasive bladder cancer undergoing intravesical BCG therapy or chemotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HR NMIBC group; High Risk (HR) NMIBC group of participants studied include ones with American Urological Association (AUA) / Society of Urologic Oncology (SUO) criteria such as : high grade T1, recurrent high grade Ta, high grade Ta >3 cm, multifocal high grade Ta, any Carcinoma in-situ (CIS), any BCG failure in high grade disease, any variant histology, any lymphovascular invasion. Note: Ta means the cancer is just in the innermost layer of the bladder lining. T1 means the cancer has started to grow into the connective tissue beneath the bladder lining.
IR NMIBC group; Intermediate Risk (IR) NMIBC group of participants studied include ones with AUA/SUO criteria such as : 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 Note: Ta means the cancer is just in the innermost layer of the bladder lining. T1 means the cancer has started to grow into the connective tissue beneath the bladder lining.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence free survival (RFS) at 3 months after TURBT in participants with HR NMIBC	Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 3 months.	3 months
Recurrence free survival (RFS) at 6 months after TURBT in patients with HR NMIBC	Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 6 months.	6 months
Recurrence free survival (RFS) at 12 months after TURBT in patients with HR NMIBC	Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 12 months.	12 months
Recurrence free survival (RFS) at 24 months after TURBT in patients with HR NMIBC	Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 24 months.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence free survival (RFS) at 3 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC	Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of negative surveillance cystoscopy after TURBT confirming histopathological recurrence, disease progression or death as a first event from any cause at 3 months.	3 months
Recurrence free survival (RFS) at 6 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC	Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of negative surveillance cystoscopy after TURBT confirming histopathological recurrence, disease progression or death as a first event from any cause at 6 months.	6 months
Recurrence free survival (RFS) at 12 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC	Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of negative surveillance cystoscopy after TURBT confirming histopathological recurrence, disease progression or death as a first event from any cause at 12 months.	12 months
Recurrence free survival (RFS) at 24 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC	Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of negative surveillance cystoscopy after TURBT confirming histopathological recurrence, disease progression or death as a first event from any cause at 24 months.	24 months
Progression-free survival (PFS) at 12 months following the first negative surveillance cystoscopy after TURBT in patients with HR or IR NMIBC	Progression-Free Survival is measured as the time from the patient registration to the date of first negative surveillance cystoscopy after TURBT in patients with HR or IR NMIBC or death from any cause in the absence of progression, whichever occurs first. An increase in tumor stage and/or the presence of muscle invasive disease diagnosed during surveillance cystoscopy will constitute disease progression.	12 months
Progression-free survival (PFS) at 24 months following the first negative surveillance cystoscopy after TURBT in patients with HR NMIBC or IR NMIBC	Progression-Free Survival is measured as the time from the patient registration to the date of first negative surveillance cystoscopy after TURBT in patients with HR or IR NMIBC or death from any cause in the absence of progression, whichever occurs first. An increase in tumor stage and/or the presence of muscle invasive disease diagnosed during surveillance cystoscopy will constitute disease progression.	24 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Valar Labs
• Investigators: Principal Investigator: Yair Lotan, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Bladder cancer; NMIBC
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: STU-2023-0188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No