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

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


  • Org Study ID: HSC20130177H
  • Secondary ID:
  • NCT ID: NCT02298998
  • NCT Alias:
  • Sponsor: The University of Texas Health Science Center at San Antonio - Other
  • Source: The University of Texas Health Science Center at San Antonio

Brief Summary

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.

Detailed Description


This is a two-arm, randomized-controlled pilot study with 2 year duration. The intervention"
refers to surveillance based on the EAU guidelines and the "control" refers to surveillance
based on the AUA guidelines.

Research methods: Participants who presents with non-muscle invasive bladder cancer and meets
the inclusion/exclusion criteria will be given an option to participate in the study.
Participants will be enrolled at the Urology Clinics at the University of Texas Health
Science Center San Antonio (UTHSCSA) Medical Arts and Research Center (MARC) and South Texas
Veterans Health Care System (STVHCS). Non-local site include the University of Texas
Southwestern Medical Center (UTSW). The research procedures consist of urine collection,
cystoscopy, and patient satisfaction and cost questionnaires. The evaluation will be done by
the tumor recurrence and progression of the disease. At various time points throughout the
study, urine may be obtained from the patient and banked in the Genitourinary (GU) Tissue
Bank. Subjects asked to provide a urine sample(s) will be asked to sign a separate informed
consent. The urine is de-identified in the lab per the Health Insurance Portability and
Accountability Act (HIPAA) protocol GU Tissue Bank Institutional Review Board (IRB) #
20050234H). Patients will undergo cystoscopy in clinic (standard of care). In the
intervention arm, patient surveillance cystoscopy will be performed at 3, 12 months and again
at 24 months following the diagnosis of bladder cancer. Patients randomized to the control
arm, will undergo surveillance cystoscopy every 3 months for 2 years following the diagnosis
of bladder cancer. Because use of cytology is variable among the participating urologist, the
utilization of cytology will be at the treating urologist's discretion as per usual standard
care. Study duration will be 2 years from most recent biopsy. Patients will be placed on the
surveillance schedule based on the length of time from their last tumor.

Overal Status Start Date Phase Study Type
Recruiting Start Date: March 2013 N/A Observational [Patient Registry]

Primary Outcomes:

Primary Outcome 1 - Measure: Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study.

Primary Outcome 1 - Time Frame: 2 years

Primary Outcome 2 - Measure: Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance.

Primary Outcome 2 - Time Frame: 2 years

Condition:

  • Bladder Cancer

Eligibility

Criteria:
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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Robert Svatek, MD

Phone: 210-450-9600

Email: svatek@uthscsa.edu

Location

Facility Status Contact
The University of Texas Health Science Center
San Antonio, Texas 78229
United States
Recruiting Kerri Kendrick, PAC
210-567-5676
kendrick@uthscsa.edu