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Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
Trial Status: active
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.
Inclusion Criteria
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
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
Exclusion Criteria
History of total cystectomy of the bladder.
History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).
History of muscle-invasive bladder tumor.
Pregnancy or lactation.
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)
Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
Inability to provide a voided urine sample.
Additional locations may be listed on ClinicalTrials.gov for NCT05796375.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South Carolina
Status: Active
Name Not Available
Texas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not Available
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.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationWhite River Junction Veterans Affairs Medical Center
