Predicting Outcomes in Intermediate and High-risk Non-muscle Invasive Bladder Cancer Using Automated Analysis of Digital Pathology Data
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Jacob Taylor, MD
Jacob.Taylor@UTSouthwestern.edu
214-645-8791
Backup
Sonobia Garrett
Sonobia.Garrett@UTSouthwestern.edu
2146458482
Time Frame
Start Date:2024-01-25
Estimated Completion Date:2026-09
Participants
Target number of participants:600
Treatments
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.