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BRIEF TITLE: Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Observation Versus Immediate Surgery of Low Risk Bladder Cancer

  • Org Study ID: 151898
  • Secondary ID:
  • NCT ID: NCT02700724
  • NCT Alias:
  • Sponsor: Vanderbilt University Medical Center - Other
  • Source: Vanderbilt University Medical Center

Brief Summary

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

Overal Status Start Date Phase Study Type
Recruiting Start Date: April 2016 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Event-Free Survival

Primary Outcome 1 - Time Frame: 12 months


  • Bladder Cancer


Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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
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Gender: All

Minimum Age: 50 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Daniel D. Lee, MD

Role: Principal Investigator

Affiliation: Vanderbilt University Medical Center

Overall Contact

Name: Daniel Lee, MD




Facility Status Contact
Vanderbilt University Medical Center
Nashville, Tennessee
United States
Recruiting D