The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study 2
This study compares how two common treatments for bladder cancer, bladder-sparing therapy and surgery to remove the bladder, can affect patients' health, quality of life, and experiences, as well as the experiences of their caregivers.
Inclusion Criteria
- PATIENT PARTICIPANTS: * Adult 18 years of age or older; and * Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with: ** Pathology documentation from any hospital/clinic/medical center ** More than 50% urothelial carcinoma component in the specimen; and * History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and * In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment CAREGIVER PARTICIPANTS: * Adult 18 years of age or older
Exclusion Criteria
- PATIENT PARTICIPANTS: * Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation) * Previous history of cystectomy or radiation therapy for bladder cancer * Previous history of muscle-invasive bladder cancer or metastatic bladder cancer * Untreated or current urinary tract urothelial carcinoma outside of the bladder (e.g. ureters, renal pelvis, penile urethra for males, urethra for females). Urinary tract cancer outside of the bladder treated more than 2 years ago is not an exclusion * Incarcerated in a detention facility or in police custody at baseline/screening (patients wearing a monitoring device can be enrolled) * Contraindication to radical cystectomy (e.g., ASA of 4, patient not considered a radical cystectomy candidate due to comorbidity) * Contraindication to BST (i.e., intolerant of all intravesical and intravenous medical therapies) * Unable to provide written informed consent in English * Unable to be contacted for research surveys * Planning to participate in a blinded interventional clinical trial for NMIBC such that details about treatment or therapy received will be unavailable for data collection CAREGIVER PARTICIPANTS: * Unable to provide informed consent in English * Unable to be contacted for research surveys
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07225127.
Locations matching your search criteria
United States
Tennessee
Nashville
Washington
Seattle
PRIMARY OBJECTIVES:
I. To compare patient-reported and patient-centered clinical outcomes between patients undergoing radical cystectomy and those receiving BST for recurrent high-grade NMIBC.
II. To characterize the heterogeneity of treatments received for recurrent high-grade NMIBC and corresponding patient and caregiver preferences.
III. To improve the prediction of progression to muscle invasive or metastatic bladder cancer in recurrent high-grade NMIBC using precision diagnostics for better-informed treatment decisions.
IV. To compare the impact of radical cystectomy and BST on caregivers of patients with recurrent high-grade NMIBC.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 cohorts.
COHORT I: Patients complete surveys, undergo archival tissue sample collection, and have their medical records reviewed on study. Patients may also complete an interview on study.
COHORT II: Caregivers complete surveys and may also complete an interview on study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorJohn L Gore
- Primary IDRG1126118
- Secondary IDsNCI-2025-09037, CISTO 2
- ClinicalTrials.gov IDNCT07225127