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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged 18 years or older

• 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

• Stated willingness to comply with all study procedures and availability for the duration of the study

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

• Ability to consent in English or Spanish

Locations
United States
Connecticut
West Haven VA Medical Center
RECRUITING
West Haven
Florida
Bay Pines VA Healthcare System
RECRUITING
Bay Pines
Massachusetts
VA Boston Jamaica Plains Campus
RECRUITING
West Roxbury
Missouri
VA St.Louis Healthcare System
RECRUITING
St Louis
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Vermont
White River Junction Veterans Healthcare System
RECRUITING
White River Junction
Contact Information
Primary
Florian R Schroeck, MD, MS
florian.schroeck@va.gov
802-295-9363
Backup
Laura Jensen, MPH
Laura.Jensen@va.gov
802-280-5298
Time Frame
Start Date: 2023-11-17
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 240
Treatments
Active_comparator: Frequent Cystoscopy
Cystoscopy is conducted at 6, 12, 18, and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer
Experimental: Xpert Urine Test
Xpert arm includes urine testing using the Xpert Bladder Cancer Monitor urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer
Experimental: EpiCheck Urine Text
EpiCheck arm includes urine testing using the Bladder EpiCheck urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer.
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of South Carolina, National Cancer Institute (NCI), University of Texas Southwestern Medical Center
Leads: White River Junction Veterans Affairs Medical Center

This content was sourced from clinicaltrials.gov