Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study

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Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study

Condition: Bladder Cancer

Intervention:

  • Other: Intervention
  • Other: Control

Purpose: This is a two-arm, randomized-controlled pilot study with 2 year duration. The “intervention” refers to surveillance based on the European Association of Urology (EAU) guidelines and the “control” refers to surveillance based on the American Urological Association (AUA) guidelines.

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02298998

Sponsor: The University of Texas Health Science Center at San Antonio

Primary Outcome Measures:

  • Measure: Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study.
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance.
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms.
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Compare proportion of patients experiencing disease progression and recurrence at 2 years following most recent biopsy under two different surveillance approaches.
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 50

Study Start Date: March 2013

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Must have non-muscle invasive low-grade, papillary (Ta) bladder cancer.
  • Must have a negative cystoscopy following most recent biopsy.
  • Must be able to give informed consent.
  • Must be age 18 or older.
  • Must be at low- or low-intermediate risk for disease recurrence and progression according to the EAU guidelines.

Exclusion Criteria:

  • Have a history of invasive (>=T1) bladder cancer.
  • Have a history of carcinoma-in-situ (CIS).
  • Unable to give informed consent.
  • < 18 or younger.
  • Variant histology (micropapillary, nested variant, non-urothelial cell carcinoma elements).
  • Had a surveillance cystoscopy following most recent biopsy.

Contact:

  • Robert Svatek, MD
  • 210-450-9600

Location:

  • The University of Texas Health Science Center
  • San Antonio Texas 78229 United States

View trial on ClinicalTrials.gov

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