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AI Tool for Non-muscle Invasive Bladder Cancer

This study is developing an Artificial Intelligence (AI) tool to help predict how well people with non-muscle invasive bladder cancer (NMIBC) will respond to treatments like Bacillus Calmette-Guérin (BCG) and chemotherapy. The goal is to identify which patients are most likely to benefit from these treatments, or if other options like clinical trials or surgery might be better. Researchers will analyze tissue samples from your bladder tumor to create and test this AI tool. The study is looking for 600 participants between 18 and 99 years old who have intermediate or high-risk NMIBC. Success will be measured by how long patients remain free from cancer recurrence at 3, 6, and 12 months after their initial surgery (TURBT). The current recruitment status is unclear.

Study design
This is an observational study involving 600 participants. It aims to develop and validate an AI-based tool.
What's involved
Analysis will be performed on your most recent tumor tissue sample from a Transurethral resection of bladder tumor (TURBT) before BCG treatment, and on samples if the cancer returns after BCG.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure recurrence-free survival at 3, 6, and 12 months after TURBT.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05825950

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

Recruiting
Not specifiedAges 18–99Observational
University of Texas Southwestern Medical Center
~600 participants
Updated 2026-08-24 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence free survival (RFS) at 3 months after TURBT in participants with HR NMIBC
Measured over 3 months
+3 more outcomes measured

Conditions

Non-muscle-invasive Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT05825950

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Yair Lotan, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Jacob Taylor, MD
[email protected]
214-645-8791
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

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

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

What this trial measures

  • Recurrence free survival (RFS) at 3 months after TURBT in participants with HR NMIBC3 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.

  • Recurrence free survival (RFS) at 6 months after TURBT in patients with HR NMIBC6 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.

  • Recurrence free survival (RFS) at 12 months after TURBT in patients with HR NMIBC12 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.

  • Recurrence free survival (RFS) at 24 months after TURBT in patients with HR NMIBC24 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.