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New treatment option for Non-muscle-invasive Bladder Cancer
Official title Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
ClinicalTrials.gov ID: NCT05796375
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
See the full eligibility 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
- 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
- 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...
- Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
- Inability to provide a voided urine sample.
The study team makes the final eligibility decision.
Where it's taking place
- West Haven, Connecticut, United States
- Bay Pines, Florida, United States
- Tampa, Florida, United States
- West Roxbury, Massachusetts, United States
- St Louis, Missouri, United States
- Cleveland, Ohio, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- White River Junction, Vermont, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Haven, Connecticut, United States; Bay Pines, Florida, United States; Tampa, Florida, United States; West Roxbury, Massachusetts, United States; St Louis, Missouri, United States; Cleveland, Ohio, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.