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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer, CISTO Study

This study compares therapy within the bladder (intravesical therapy) and surgery as treatment options for patients with bladder cancer. Bladder cancer is the fifth most common cancer in the United States, but not enough research is available to help patients decide between the two most common treatments: medical therapies or bladder removal. The purpose of this study is to compare how the two treatments affect patient clinical outcomes and patient and caregiver experiences. This study may help researchers improve the decision-making process about bladder cancer treatments for patients and their caregivers.
Bladder
N/A
Adults
Not Available
Not Available
Scarpato, Kristen
National
Vanderbilt University
01-12-2020
Health Services Research
VICCURO19105
NCT03933826

Eligibility

18 Years
BOTH
YES
Inclusion Criteria:

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, and * 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

Caregiver



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., American Society of Anesthesiologists Classification [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

CAREGIVER: Unable to provide written informed consent in English

CAREGIVER: Unable to be contacted for research surveys

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