AI tool to predict treatment response in bladder cancer
Predicting Outcomes in Intermediate and High-risk Non-muscle Invasive Bladder Cancer Using Automated Analysis of Digital Pathology Data
This study is testing a new AI tool that helps doctors predict how well bladder cancer patients will respond to certain treatments, so they can make better choices for those at risk of their cancer coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT05825950 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with intermediate or high-risk non-muscle invasive bladder cancer.
Not a fit: Patients with inadequate tissue samples or those with muscle-invasive bladder cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly improve treatment personalization and outcomes for patients with NMIBC.
How similar studies have performed: Other studies have shown promise in using AI for predictive analytics in cancer treatment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.