Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05825950
Status
Recruiting
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Conditions

  • Non-muscle-invasive Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 25, 2024
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: HR NMIBC group
    High Risk (HR) NMIBC group of participants studied include ones with American Urological Association (AUA) / Society of Urologic Oncology (SUO) criteria such as : high grade T1, recurrent high grade Ta, high grade Ta \>3 cm, multifocal high grade Ta, any Carcinoma in-situ (CIS), any BCG failure in high grade disease, any variant histology, any lymphovascular invasion. Note: Ta means the cancer is just in the innermost layer of the bladder lining. T1 means the cancer has started to grow into the connective tissue beneath the bladder lining.
  • Arm: IR NMIBC group
    Intermediate Risk (IR) NMIBC group of participants studied include ones with AUA/SUO criteria such as : 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 Note: Ta means the cancer is just in the innermost layer of the bladder lining. T1 means the cancer has started to grow into the connective tissue beneath the bladder lining.

Primary Outcome Measure

Recurrence free survival (RFS) at 3 months after TURBT in participants with HR NMIBC [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390-9164
Sonobia Garrett
[email protected]
2146458482
Solomon Woldu, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Brandi Weaver
[email protected]
210-567-0178
Robert Svatek, MD (PRINCIPAL_INVESTIGATOR)

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