NCT05825950Recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 11 Apr 2023
- Start date
- 25 Jan 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Bladder cancer
- NCT number
- NCT05825950
What you commit to
- Study type: Observational
- Planned participants: 600
- From 25 Jan 2024 to the primary completion date, Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic therapy
Other illness
- ≥ T2 bladder cancer
Other
- Inadequate tissue from TURBT
- Inability to read or write English or Spanish
- Unwilling to sign written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.