A Study to Compare Intravesical Therapy and Surgery to Treat Bladder Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 21-002166
NCT ID: NCT03933826
Sponsor Protocol Number: CISTO
About this study
The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Bladder cancer is the most common urinary tract cancer and the 5th 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 (CISTO) for Bladder Cancer Study 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult 18 years of age or older.
- 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;
- History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1;
- Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time;
- Received at least one instillation of any intravesical agent within previous 12 months.
Exclusion Criteria:
- 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.
- Any history of upper tract urothelial carcinoma.
- Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening.
- Contraindication to radical cystectomy (e.g., ASA of 4).
- Contraindication to medical therapy (i.e., intolerant of all medical therapies).
- Unable to provide written informed consent in English.
- Unable to be contacted for research surveys.
- Planning to participate in a Phase I/II interventional clinical trial for NMIBC or any blinded interventional trial for NMIBC.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Mark Tyson, M.D., M.P.H. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available