Replacing Invasive Bladder Checks with Urine Tests for Monitoring Early-Stage Bladder Cancer
Sponsor: White River Junction Veterans Affairs Medical Center
ClinicalTrials ID:NCT05796375
This study is exploring whether urine tests can replace some of the invasive bladder checks (cystoscopies) for monitoring early-stage bladder cancer. It aims to see if this change affects symptoms, discomfort, anxiety, or cancer outcomes.
Patient Parameters
| Parameter | Options |
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Program Overview
The study is investigating if using urine tests instead of some cystoscopies can improve the way bladder cancer is monitored. It will look at whether this change affects urinary symptoms, discomfort, anxiety, the number of invasive procedures, and cancer outcomes like recurrence or progression.
Description
This research involves 240 patients with early-stage bladder cancer and will take place at multiple locations. Participants will be randomly assigned to one of three groups: (1) Frequent Cystoscopy Group, (2) Xpert Urine Test Group, or (3) EpiCheck Urine Test Group.
- The Frequent Cystoscopy Group will have regular bladder checks using a cystoscope over two years to detect any returning cancer.
- The Xpert Urine Test Group will use the Xpert urine test to monitor for cancer recurrence, aiming to reduce the number of cystoscopies. They will have urine tests and doctor check-ups at 6 and 18 months, and cystoscopies at 12 and 24 months.
- The EpiCheck Urine Test Group will use the EpiCheck urine test with the same schedule as the Xpert group.
The study will last for 24 months, and the main focus is on how these methods affect urinary quality of life shortly after monitoring.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a history of low-grade, intermediate-risk non-muscle invasive bladder cancer, such as:
- Multiple small low-grade tumors
- A single low-grade tumor larger than 3 cm
- Recurrent low-grade tumors
- Willing to follow all study procedures and available for the entire study duration.
- No signs of cancer recurrence within 6 months after the last tumor removal.
- Able to give consent in English or Spanish.
Exclusion Criteria
- Have had the bladder completely removed.
- Have had urinary diversion surgery (e.g., neo-bladder, colon pouch).
- Have had muscle-invasive bladder cancer.
- Are pregnant or breastfeeding.
- Have had cancer in the ureter or kidney area unless treated and cancer-free.
- Have anatomical issues that make cystoscopy impossible.
- Cannot provide a urine sample.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| West Haven VA Medical Center | 06516 | West Haven | Connecticut |
| Bay Pines VA Healthcare System | 33744 | Bay Pines | Florida |
| James A. Haley Veterans' Hospital | 33612 | Tampa | Florida |
| VA Boston Jamaica Plains Campus | 02132 | West Roxbury | Massachusetts |
| VA St.Louis Healthcare System | 63016 | St Louis | Missouri |
| University Hospitals Cleveland Medical Center | 44106 | Cleveland | Ohio |
| Medical University of South Carolina | 29425 | Charleston | South Carolina |
| UT Southwestern Medical Center | 75235 | Dallas | Texas |
| White River Junction Veterans Healthcare System | 05009 | White River Junction | Vermont |
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