| Surveillance for low-risk non-muscle invasive bladder cancer: A Pilot Study | |||
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| Principal Investigator: Robert Svatek, MD | IRB #: | ||
| Department Address: Department of Urology, 7703 Floyd Curl Drive, San Antonio, TX 78229 |
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| Contact Person:
Izelda Zarate |
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Enrollment Notes: patients with bladder cancer |
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| The target age is: 18years of age | |||
Study Begin and End Date: January 2013- January 2015 |
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Eligibility Criteria: Men or women with a diagnosis of "superficial" (non-muscle invasive bladder cancer) |
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Type of Study: Intervention |
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| Funding Source: Cancer Therapy and Research Center | |||
| Detailed description of this study | |||
| In the U.S., guidelines for following patients with non-muscle invasive bladder cancer indicate that patients should undergo cystoscopy every 3 months for the first 2 years after diagnosis, then every 6 months for the next 2 years, and then yearly. This recommendation is based on expert opinion (Level 4 evidence). The European Association Urology (EAU) recommends a less frequent followup scheme (see Treatment plan below). Although such an approach could considerably decrease costs and burden during the follow-up period by examining patients less frequently, to date these surveillance approaches have never been assessed in a prospective manner. The goal of the study is to compare these 2 different approaches to surveillance for bladder cancer in terms of progression rates, direct and indirect costs, and patient satisfaction.
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Title: Phase III blinded study of immediate post-TURBT instillation of Gemcitabine versus Saline in patients with newly diagnosed or occasionally recurring grade I/II superficial bladder cancer.