Bladder Cancer Clinical Trial

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

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.

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Full Description

Analysis will be performed on the most recent Transurethral resection of bladder tumor (TURBT) histologic specimen obtained prior to BCG induction and on histologic specimens at time of recurrence after BCG induction. This stratification is of potential utility to clinicians for patient counseling purposes, for the identification of patients likely to benefit from induction or re-induction with BCG, and for consideration of alternative treatment strategies including clinical trials, chemotherapy, or cystectomy. Additionally, there is currently no reliable tool for identifying which NMIBC patients are most likely to benefit from adjuvant BCG versus intravesical chemotherapy. This is of current relevance in the management of Intermediate-risk (IR) NMIBC since both BCG and chemotherapy are first-line treatment options and will likely become of increasing relevance in High-risk (HR) NMIBC as efficacious first-line alternatives to intravesical BCG are introduced into clinical practice. In the proposed prospective study, the study team also aims to develop and then validate an AI-based histologic analysis tool for clinicians that is intended to predict recurrence following intravesical chemotherapy in IR and HR NMIBC patients.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Bladder Cancer

Estimated Enrollment:

600

Study ID:

NCT05825950

Recruitment Status:

Recruiting

Sponsor:

University of Texas Southwestern Medical Center

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There is 1 Location for this study

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University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Sonobia Garrett
Contact
214-645-8482
[email protected]
Holly L Ford
Contact
2146458790
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

600

Study ID:

NCT05825950

Recruitment Status:

Recruiting

Sponsor:


University of Texas Southwestern Medical Center

How clear is this clinincal trial information?

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