Clinical trial NCT02298998: Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study
Official title: Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a history of low or low-intermediate risk non-muscle invasive bladder cancer. They are being followed with periodic examinations of their bladder as a means for cancer surveillance.

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.

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.

Primary outcomes:
measure: Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study.
timeFrame: 2 years
measure: Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance.
timeFrame: 2 years
Secondary outcomes:
measure: Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms.
timeFrame: 2 years
measure: Compare proportion of patients experiencing disease progression and recurrence at 2 years following most recent biopsy under two different surveillance approaches.
timeFrame: 2 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
References: