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Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)
RECRUITINGSponsored by University of Texas Southwestern Medical Center
Actively Recruiting
SponsorUniversity of Texas Southwestern Medical Center
Started2024-01-25
Est. completion2026-09
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05825950
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
Age: 18 Years – 99 YearsHealthy volunteers accepted
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
Conditions2
CancerNon-Muscle Invasive Bladder Cancer
Locations2 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9164
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
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Actively Recruiting
SponsorUniversity of Texas Southwestern Medical Center
Started2024-01-25
Est. completion2026-09
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05825950