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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

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
Sonobia Garrett2146458482Sonobia.Garrett@UTSouthwestern.edu
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Brandi Weaver210-567-0178WeaverB@uthscsa.edu

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