Recruiting

Artificial Intelligence

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05825950

Conditions

Non-muscle-invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Non-muscle-invasive Bladder Cancer

Study ID

NCT05825950

Start date

Jan 25, 2024

Status verified date

Aug, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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 ]
  • Recurrence free survival (RFS) at 6 months after TURBT in patients with HR NMIBC [ Time Frame: 6 months ]
  • Recurrence free survival (RFS) at 12 months after TURBT in patients with HR NMIBC [ Time Frame: 12 months ]
  • Recurrence free survival (RFS) at 24 months after TURBT in patients with HR NMIBC [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Jacob Taylor, MD

214-645-8791Jacob.Taylor@UTSouthwestern.edu

Sonobia Garrett

2146458482Sonobia.Garrett@UTSouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-9164

Contacts

Sonobia Garrett

2146458482Sonobia.Garrett@UTSouthwestern.edu

Principal Investigator:

Solomon Woldu, MD

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Brandi Weaver

210-567-0178WeaverB@uthscsa.edu

Principal Investigator:

Robert Svatek, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • NMIBC
  • Bladder cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-08-24.