AI tool to predict treatment response in bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center observational study aims to develop and validate an AI-based histologic analysis tool that predicts responsiveness to intravesical Bacillus Calmette-Guérin (BCG) and chemotherapy in patients with intermediate and high-risk non-muscle invasive bladder cancer (NMIBC). The analysis will utilize histologic specimens obtained from patients prior to BCG induction and at recurrence after treatment. The tool is intended to assist clinicians in counseling patients and identifying those who may benefit from specific treatments or alternative strategies. This study addresses a critical gap in the management of NMIBC, particularly for patients who are at intermediate or high risk of recurrence.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• University of Texas Health Science Center at San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Yair Lotan, MD — University of Texas Southwestern Medical Center
• Study coordinator: Jacob Taylor, MD
• Email: Jacob.Taylor@UTSouthwestern.edu
• Phone: 214-645-8791

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

  Recruiting Natera, Inc. · Austin, Texas · NCT07763197

• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

  This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.

  Recruiting Phase 2 Blokhin's Russian Cancer Research Center · Moscow, Moscow · NCT07747740

• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

  This study tests whether patients who have become tumor-free after a systemic immunotherapy-based bladder-sparing treatment can safely stop therapy and instead be watched closely.

  Recruiting at 4 sites Phase 2 Tianjin Medical University Second Hospital · Tianjin and 3 other locations · NCT07625527

• Comparing CT and MRI with VI-RADS for Bladder Cancer Staging

  This study tests how well CT and MRI with VI-RADS can correctly stage bladder cancer before surgery in adults.

  Recruiting Oslo University Hospital · Oslo · NCT07602010

• How bladder microbes and immune signals affect lower urinary tract health

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  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07494864

• Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

  This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).

  Recruiting at 14 sites Phase 2 Lepu Biopharma Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT07283835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.