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

• ClinicalTrials.gov Identifier: NCT02298998
• Recruitment Status: Completed
• First Posted: November 24, 2014
• Last Update Posted: June 14, 2021
• Sponsor: The University of Texas Health Science Center at San Antonio
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

Study Description

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.

Condition or disease	Intervention/treatment
Bladder Cancer	Other: Intervention; Other: Control

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 41 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study
• Study Start Date: March 2013
• Actual Primary Completion Date: May 28, 2021
• Actual Study Completion Date: June 7, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Intervention; The intervention group refers to surveillance based on the EAU guidelines.	Other: Intervention; Patients randomized into the intervention group will follow the European Urologic Association (EAU) surveillance guidelines for cystoscopy follow-ups during bladder cancer surveillance.; Other Name: EAU surveillance
Control; The control group refers to surveillance based on the AUA guidelines.	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.; Other Name: AUA Surveillance

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms. [ Time Frame: 2 years ]
2. 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 ]

Biospecimen Retention:   Samples With DNA

After participant signs the consent form, research staff may ask participant to provide a urine sample at each study visit for research purposes.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Locations

United States, Texas

The University of Texas Health Science Center

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

More Information

Additional Information:

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT02298998
• Other Study ID Numbers: HSC20130177H
• First Posted: November 24, 2014
• Last Update Posted: June 14, 2021
• Last Verified: June 2021

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type