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NCT05796375RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
240 (estimated)
First submitted
21 Mar 2023
Start date
17 Nov 2023
Primary completion date
30 Nov 2028
Lead sponsor
White River Junction Veterans Affairs Medical Center
NCT number
NCT05796375

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 240
  • From 17 Nov 2023 to the primary completion date, 30 Nov 2028
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • 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).

Other

  • Pregnancy or lactation.
  • Inability to provide a voided urine sample.

Who the study is looking for

  • 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 ≤6 months after most recent tumor resection
  • Ability to consent in English or Spanish

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bay Pines VA Healthcare System
Coordinator of this site? Confirm its status
Bay PinesUnited StatesRecruiting
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesActive, not recruiting
University Hospitals Cleveland Medical Center*
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
UT Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Dartmouth Hitchcock Medical Center
Coordinator of this site? Confirm its status
LebanonUnited StatesRecruiting
VA St. Louis Healthcare System
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
James A. Haley Veterans Hospital
Coordinator of this site? Confirm its status
TampaUnited StatesWithdrawn
West Haven VA Medical Center
Coordinator of this site? Confirm its status
West HavenUnited StatesRecruiting
VA Boston Jamaica Plains Campus
Coordinator of this site? Confirm its status
West RoxburyUnited StatesRecruiting
White River Junction Veterans Healthcare System
Coordinator of this site? Confirm its status
White River JunctionUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.