NCT07225127 Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
| NCT ID | NCT07225127 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 408 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 408 participants in total. It began in 2025-11-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Adult 18 years of age or older; and 2. Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with: 1. Pathology documentation from any hospital/clinic/medical center 2. More than 50% urothelial carcinoma component in the specimen; and 3. History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and 4. 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. Exclusion Criteria: 1. Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation); 2. Previous history of cystectomy or radiation therapy for bladder cancer; 3. Previous history of muscle-invasive bladder cancer or metastatic bladder cancer; 4. 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; 5. Incarcerated in a detention facility or in police custody at baseline/screening (patients wearing a monitoring device can be enrolled); 6. Contraindication to radical cystectomy (e.g., ASA of 4, patient not considered a radical cystectomy candidate due to comorbidity); 7. Contraindication to BST (i.e., intolerant of all intravesical and intravenous medical therapies); 8. Unable to provide written informed consent in English; 9. Unable to be contacted for research surveys; 10. 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.
Contact & Investigator
John L Gore, MD, MS
PRINCIPAL INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Frequently Asked Questions
Who can join the NCT07225127 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07225127 currently recruiting?
Yes, NCT07225127 is actively recruiting participants. Contact the research team at cistorc@uw.edu for enrollment information.
Where is the NCT07225127 trial being conducted?
This trial is being conducted at Tampa, United States, Iowa City, United States, Chapel Hill, United States, Columbus, United States and 2 additional locations.
Who is sponsoring the NCT07225127 clinical trial?
NCT07225127 is sponsored by University of Washington. The principal investigator is John L Gore, MD, MS at Fred Hutch/University of Washington Cancer Consortium. The trial plans to enroll 408 participants.
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