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

NCT05825950 | Recruiting DMC

• 1 other identifier: STU-2023-0188
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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

Keywords

NMIBC; Bladder cancer

Outcome Measures

Primary Outcomes (4)

• Recurrence free survival (RFS) at 3 months after TURBT in participants with HR NMIBC

  Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 3 months.

  3 months

• Recurrence free survival (RFS) at 6 months after TURBT in patients with HR NMIBC

  Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 6 months.

  6 months

• Recurrence free survival (RFS) at 12 months after TURBT in patients with HR NMIBC

  Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 12 months.

  12 months

• Recurrence free survival (RFS) at 24 months after TURBT in patients with HR NMIBC

  Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 24 months.

  24 months

Secondary Outcomes (6)

• Recurrence free survival (RFS) at 3 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC

  3 months

• Recurrence free survival (RFS) at 6 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC

  6 months

• Recurrence free survival (RFS) at 12 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC

  12 months

• Recurrence free survival (RFS) at 24 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC

  24 months

• Progression-free survival (PFS) at 12 months following the first negative surveillance cystoscopy after TURBT in patients with HR or IR NMIBC

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects identified in urology clinics after a diagnosis of non-muscle invasive bladder cancer undergoing intravesical BCG therapy or chemotherapy

You may qualify if:

• 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

You may not qualify if:

• Inadequate tissue from TURBT
• ≥ T2 bladder cancer
• Systemic therapy
• Inability to read or write English or Spanish
• Unwilling to sign written informed consent

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Valar Labs: collaborator

Study Sites (2)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9164, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Yair Lotan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Taylor, MD

CONTACT

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

Sonobia Garrett

CONTACT

2146458482; Sonobia.Garrett@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: January 25, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)