Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Stopped early · Not applicable

Conditions studied: Bladder Cancer

In brief

This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.

Key facts

Study ID

NCT02700724

Run by

Vanderbilt University Medical Center

People needed

8

Starts

2016-04-01

Expected to finish

2018-07-19

Last updated by the study team

2018-08-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of low grade, noninvasive urothelial carcinoma of the bladder with a new recurrence that meets the following 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)

You may not qualify if…

• High grade and/or invasive and/or carcinoma in situ disease
• Concomitant upper tract urothelial carcinoma
• Any patient who is pregnant or who may have plans to become pregnant.
• Positive cytology

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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