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)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

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NCT05825950


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