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Brief Title: Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance

Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance

INTRODUCTION

  • Org Study ID: 1732756
  • Secondary ID: N/A
  • NCT ID: NCT05796375
  • Sponsor: White River Junction Veterans Affairs Medical Center

BRIEF SUMMARY

The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.

DETAILED DESCRIPTION

This is a multi-site randomized phase 2 trial including 240 patients with early-stage bladder cancer, in which patients will be randomized 1:1:1 to programmatic surveillance with the Xpert bladder cancer urine test, the Bladder EpiCheck urine test, or frequent cystoscopy. The primary outcome will be urinary quality of life measured 1 to 3 days after surveillance.

This study will have three groups, also called "arms": (1) Frequent Cystoscopy Arm, (2) Xpert Urine Test Arm, and (3) Epicheck Urine Test Arm. The aim of Frequent Cystoscopy is to detect any cancer that might have come back within the bladder by frequently inspecting the bladder. Those in the cystoscopy arm will have a cystoscopy procedure at specified time points for two years. The goal of the Xpert Urine Test arm is to detect any cancer that might have come back within the bladder, while decreasing the number of invasive cystoscopy procedures. Those in the Xpert arm will have a Xpert urine test and a check-up with a medical doctor at 6 months and 18 months, and have a cystoscopy procedure at 12 months and 24 months. The aim of the EpiCheck Urine Test arm is to detect any cancer that might have come back within the bladder, while decreasing the number of invasive cystoscopy procedures. Those in the EpiCheck Urine Test arm will have an Epicheck urine test and a check-up with a medical doctor at 6 months and 18 months and will have a cystoscopy procedure at 12 months and 24 months. The study performance period is 24 months.

  • Overall Status
    Recruiting
  • Start Date
    November 17, 2023
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Non-muscle-invasive Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
1. Aged 18 years or older

- 2. History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following:
* multifocal low grade non-invasive urothelial carcinoma of any size

- * solitary low grade non-invasive urothelial carcinoma greater than 3cm in size

- * recurrent low grade non-invasive urothelial carcinoma

- 3. Stated willingness to comply with all study procedures and availability for the duration of the study

- 4. No evidence for recurrence at cystoscopy ≤4 months after most recent tumor resection

- 5. Ability to consent in English or Spanish
Exclusion Criteria:
1. History of total cystectomy of the bladder.

- 2. History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).

- 3. History of muscle-invasive bladder tumor.

- 4. Pregnancy or lactation.

- 5. History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion)

- 6. Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).

- 7. Inability to provide a voided urine sample.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Florian R Schroeck, MD, MS

Role: Principal Investigator

Affiliation: White River Junction VA Healthcare System

Overall Contact

Name: Florian R Schroeck, MD, MS, Laura Jensen, MPH

Phone: 802-295-9363, 802-280-5298

Email: florian.schroeck@va.gov, Laura.Jensen@va.gov

LOCATION

Facility Status Contact
Facility: Medical University of South Carolina
Charleston, South Carolina 29425
United States 		Status: Recruiting Contact: Contact
Robert Grubb, MD

Contact
Jessica Jenkins
843-846-0630
jenkijn@musc.edu
Facility: UT Southwestern Medical Center
Dallas, Texas 75235
United States 		Status: Recruiting Contact: Contact
Sonobia Garrett, BSHS
Sonobia.Garrett@utsouthwestern.edu

Principal Investigator
Yair Lotan, MD
Facility: White River Junction Veterans Healthcare System
White River Junction, Vermont 05009
United States 		Status: Recruiting Contact: Contact
Laura L Jensen, MPH
Laura.Jensen@va.gov

Principal Investigator
Florian R Schroeck, MD, MS

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