RecruitingPhase 2

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

United States240 participantsStarted 2023-11-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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:
✓. 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

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.

What they're measuring

Quality of Life Questionnaire-Non-Muscle Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24)

Timeframe: Assessed at 3, 6, 12, 18, and 24 months.

Trial details

NCT IDNCT05796375

SponsorWhite River Junction Veterans Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2028-11-30

Contact for this trial

Prabhavathi Loganathan, MS

802-295-9363 Prabhavath.Loganathan@va.gov

View on ClinicalTrials.gov More Non-muscle-invasive Bladder Cancer trials