Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
SUMMARY

Bladder cancer is the most common urinary tract cancer and the 6th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer Study 2 (CISTO2) has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO2 is to conduct a large prospective study that directly compares the impact of bladder sparing therapies versus bladder removal in recurrent high-grade NMIBC patients on financial toxicity, clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
H. Lee Moffitt Cancer Center & Research Institute
NOT_YET_RECRUITING
Tampa
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
North Carolina
University of North Carolina
NOT_YET_RECRUITING
Chapel Hill
Ohio
The Ohio State University
NOT_YET_RECRUITING
Columbus
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Washington
University of Washington
RECRUITING
Seattle
Time Frame
Start Date: 2025-11-03
Estimated Completion Date: 2028-12
Participants
Target number of participants: 408
Treatments
Patients who have selected radical cystectomy
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
Patients who have selected bladder-sparing therapy
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
Caregivers of patients who have selected radical cystectomy
Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
Caregivers of patients who have selected bladder-sparing therapy
Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
Related Therapeutic Areas
Sponsors
Leads: University of Washington
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov