Trial Title:
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
NCT ID:
NCT05796375
Condition:
Non-muscle-invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
Bladder
Cancer
Urology
Cystoscopy
Xpert
EpiCheck
Urine test
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Health care delivery parallel trial with 1:1:1 randomization
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cystoscopy
Description:
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted
into a patient's urethra.
Arm group label:
EpiCheck Urine Text
Arm group label:
Frequent Cystoscopy
Arm group label:
Xpert Urine Test
Intervention type:
Diagnostic Test
Intervention name:
Bladder EpiCheck urine test
Description:
The Bladder EpiCheck is a laboratory-developed test for early-stage non-muscle invasive
bladder cancer. The Bladder EpiCheck test is a DNA methylation test that is run on DNA
extracted from cell pellet from centrifuged urine according to Standardized Operating
Procedures. The test has internal controls and a dedicated software to ensure required
quality assurance processes and prompt reporting of results.
Arm group label:
EpiCheck Urine Text
Intervention type:
Diagnostic Test
Intervention name:
Xpert Bladder Cancer Monitor urine test
Description:
A 4.5 ml sample of voided urine is added to Xpert® Urine Transport Reagent, mixed, and
then 4ml of treated urine are transferred to the Sample Chamber of the cartridge. In the
cartridge, cells in the urine sample are captured on a filter and lysed by sonication.
The released nucleic acid is eluted, mixed with dry RT-PCR reagents, and the solution is
transferred to the reaction tube for RT-PCR and detection.
Arm group label:
Xpert Urine Test
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.
Criteria for eligibility:
Criteria:
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
Locations:
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Grubb, MD
Contact backup:
Last name:
Jessica Jenkins
Phone:
843-846-0630
Email:
jenkijn@musc.edu
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sonobia Garrett, BSHS
Email:
Sonobia.Garrett@utsouthwestern.edu
Investigator:
Last name:
Yair Lotan, MD
Email:
Principal Investigator
Facility:
Name:
White River Junction Veterans Healthcare System
Address:
City:
White River Junction
Zip:
05009
Country:
United States
Status:
Recruiting
Contact:
Last name:
Laura L Jensen, MPH
Email:
Laura.Jensen@va.gov
Investigator:
Last name:
Florian R Schroeck, MD, MS
Email:
Principal Investigator
Start date:
November 17, 2023
Completion date:
December 30, 2028
Lead sponsor:
Agency:
White River Junction Veterans Affairs Medical Center
Agency class:
U.S. Fed
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Collaborator:
Agency:
Medical University of South Carolina
Agency class:
Other
Source:
White River Junction Veterans Affairs Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05796375
