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Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
RECRUITINGPhase 2Sponsored by White River Junction Veterans Affairs Medical Center
Actively Recruiting
PhasePhase 2
SponsorWhite River Junction Veterans Affairs Medical Center
Started2023-11-17
Est. completion2028-11-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →
NCT05796375
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
Age: 18 Years+Healthy volunteers accepted
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 ≤6 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.
Conditions2
CancerNon-Muscle Invasive Bladder Cancer
Locations8 sites
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
VA Boston Jamaica Plains Campus
West Roxbury, Massachusetts, 02132
VA St.Louis Healthcare System
St Louis, Missouri, 63016
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
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Actively Recruiting
PhasePhase 2
SponsorWhite River Junction Veterans Affairs Medical Center
Started2023-11-17
Est. completion2028-11-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →
NCT05796375