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NCT Number: NCT05825950

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

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.

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Key information

Conditions

Non-muscle-invasive Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern Medical Center, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recurrence free survival (RFS) at 3 months after TURBT in participants with HR NMIBC

    Time frame: 3 months

    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.

  2. Recurrence free survival (RFS) at 6 months after TURBT in patients with HR NMIBC

    Time frame: 6 months

    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.

  3. Recurrence free survival (RFS) at 12 months after TURBT in patients with HR NMIBC

    Time frame: 12 months

    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.

  4. Recurrence free survival (RFS) at 24 months after TURBT in patients with HR NMIBC

    Time frame: 24 months

    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.

Secondary outcomes

  1. Recurrence free survival (RFS) at 3 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC

    Time frame: 3 months

    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.

  2. Recurrence free survival (RFS) at 6 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC

    Time frame: 6 months

    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.

  3. Recurrence free survival (RFS) at 12 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC

    Time frame: 12 months

    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.

  4. Recurrence free survival (RFS) at 24 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC

    Time frame: 24 months

    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.

  5. Progression-free survival (PFS) at 12 months following the first negative surveillance cystoscopy after TURBT in patients with HR or IR NMIBC

    Time frame: 12 months

    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.

  6. Progression-free survival (PFS) at 24 months following the first negative surveillance cystoscopy after TURBT in patients with HR NMIBC or IR NMIBC

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Taylor, MD

CONTACT

[email protected]

214-645-8791

Sonobia Garrett

CONTACT

[email protected]

2146458482

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Valar Labs

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2023
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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