RecruitingNCT05825950
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
Sponsor
University of Texas Southwestern Medical Center
Enrollment
600 participants
Start Date
Jan 25, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria5
- 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 Criteria5
- Inadequate tissue from TURBT
- ≥ T2 bladder cancer
- Systemic therapy
- Inability to read or write English or Spanish
- Unwilling to sign written informed consent
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05825950
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