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Trial Title:
Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)
NCT ID:
NCT05825950
Condition:
Non-muscle-invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
NMIBC
Bladder cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Subjects identified in urology clinics after a diagnosis of non-muscle invasive bladder
cancer undergoing intravesical BCG therapy or chemotherapy
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Locations:
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390-9164
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sonobia Garrett
Phone:
214-645-8482
Email:
Sonobia.Garrett@UTSouthwestern.edu
Contact backup:
Last name:
Holly L Ford
Phone:
2146458790
Email:
holly.ford@utsouthwestern.edu
Start date:
January 25, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Source:
University of Texas Southwestern Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05825950
