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

NCT ID: NCT02298998

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2021-06-07

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.

Conditions

Bladder Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention

The intervention group refers to surveillance based on the EAU guidelines.

Intervention

Intervention Type: OTHER

Patients randomized into the intervention group will follow the European Urologic Association (EAU) surveillance guidelines for cystoscopy follow-ups during bladder cancer surveillance.

Control

The control group refers to surveillance based on the AUA guidelines.

Control

Intervention Type: OTHER

Patients randomized into the control group will follow the American Urologic Association (AUA) surveillance guidelines using cystoscopy ever 3 months for the first two years, and then every 6 months for 2 years.

Interventions

Intervention

Patients randomized into the intervention group will follow the European Urologic Association (EAU) surveillance guidelines for cystoscopy follow-ups during bladder cancer surveillance.

Intervention Type: OTHER

Control

Patients randomized into the control group will follow the American Urologic Association (AUA) surveillance guidelines using cystoscopy ever 3 months for the first two years, and then every 6 months for 2 years.

Intervention Type: OTHER

Other Intervention Names

EAU surveillance; AUA Surveillance

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Texas Health Science Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20130177H

Identifier Type: -

Identifier Source: org_study_id