This trial studies how well urothelial bladder cancer can be detected through a procedure called a rigid cystourethroscopy at the time of radical cystectomy and to determine if genomic and molecular signatures of urothelial bladder tumors can help in diagnosis and treatment. The main goal of this trial is to identify patients who are at lowest risk of harboring residual cancer after undergoing endoscopic treatments and/or chemotherapy and offer safe alternative to bladder removal.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02968732.
PRIMARY OBJECTIVES:
I. To evaluate the accuracy of endoscopic assessment in predicting pT0 urothelial disease in the urinary bladder at the time of radical cystectomy.
SECONDARY OBJECTIVES:
I. To determine if genomic tumor signatures from pre-treatment tumor tissue or immune phenotype from peripheral blood obtained prior to neoadjuvant chemotherapy can predict chemotherapy response.
II. To determine how genomic tumor signatures compare before and after chemotherapy administration.
III. To determine if genomic signature from tissue obtained on endoscopic evaluation just prior to cystectomy can help predict final pathologic stage.
OUTLINE:
Patients undergo standard rigid cystourethroscopy on the day of radical cystectomy. Patients also undergo blood sample collection throughout the study.
After completion of study, patients are followed up 1-2 weeks, every 3-6 months for 2 years, and every 6-12 months for 3 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorAlexander Kutikov
