Observation Versus Immediate Surgery of Low Risk Bladder Cancer
NCT ID: NCT02700724
Last Updated: 2018-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2016-04-30
2018-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Observation
Patients will not undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Surgery will commence after 12 months of observation or sooner if cystoscopic evidence of disease progression or patient desire.
Observation
Surveillance Cystoscopy and Urinary Cytology
Cytology and cystoscopy are done at the same time
Immediate Surgery
Patients will undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Repeated surgery will be offered for additional recurrences.
Immediate Surgery
Surveillance Cystoscopy and Urinary Cytology
Cytology and cystoscopy are done at the same time
Interventions
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Immediate Surgery
Observation
Surveillance Cystoscopy and Urinary Cytology
Cytology and cystoscopy are done at the same time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* total tumor burden ≤3cm in size (multiple lesions permitted)
* low grade appearance (grade 1 or grade 2)
* noninvasive appearance (Ta)
* no history of carcinoma in situ (CIS) or lesions concerning for CIS
* negative urine cytology (atypical or suspicious for low grade neoplasm are acceptable)
Exclusion Criteria
* Concomitant upper tract urothelial carcinoma
* Any patient who is pregnant or who may have plans to become pregnant.
* Positive cytology
50 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Daniel Lee
Instructor
Principal Investigators
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Daniel D. Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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151898
Identifier Type: -
Identifier Source: org_study_id
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