← Back to Search

Urine Testing vs Cystoscopy for Bladder Cancer Surveillance (ReplaceCysto Trial)

N/A

Recruiting

Led By Florian R Schroeck, MD, MS

Research Sponsored by White River Junction Veterans Affairs Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to consent in English or Spanish

History of low grade intermediate-risk non-muscle invasive bladder cancer as defined by specific pathology report criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 3, 6, 12, 18, and 24 months.

Awards & highlights

ReplaceCysto Trial Summary

This trial looks at whether urine tests can replace some cystoscopy procedures for bladder cancer monitoring, reducing discomfort & invasive procedures while maintaining accuracy.

Who is the study for?

This trial is for adults over 18 who can consent in English or Spanish, have a history of low-grade intermediate-risk non-muscle invasive bladder cancer, and are willing to follow the study's procedures. Pregnant women, those with total bladder removal or urinary diversions, muscle-invasive tumors, upper tract disease unless surgically treated and recurrence-free, or anatomic issues preventing cystoscopy cannot join.Check my eligibility

What is being tested?

The study aims to see if urine tests (Xpert Bladder Cancer Monitor and Bladder EpiCheck) can replace some cystoscopy procedures for monitoring bladder cancer. It will assess changes in urinary symptoms, discomfort levels, anxiety, complications as well as rates of cancer detection and progression.See study design

What are the potential side effects?

Since this trial involves non-invasive urine testing compared to the more invasive cystoscopy procedure; side effects may include discomfort from providing a urine sample versus potential risks associated with repeated cystoscopies such as bleeding or infection.

ReplaceCysto Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can give my consent in English or Spanish.

Select...

I have a history of a certain type of bladder cancer that is not aggressive.

ReplaceCysto Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 3, 6, 12, 18, and 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 3, 6, 12, 18, and 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 3, 6, 12, 18, and 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

ReplaceCysto Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Xpert Urine TestExperimental Treatment2 Interventions

Xpert arm includes urine testing using the Xpert Bladder Cancer Monitor urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer

Group II: EpiCheck Urine TextExperimental Treatment2 Interventions

EpiCheck arm includes urine testing using the Bladder EpiCheck urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer.

Group III: Frequent CystoscopyActive Control1 Intervention

Cystoscopy is conducted at 6, 12, 18, and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cystoscopy

2016

Completed Phase 4

~810

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaOTHER

933 Previous Clinical Trials

7,394,396 Total Patients Enrolled

White River Junction Veterans Affairs Medical CenterLead Sponsor

28 Previous Clinical Trials

16,641 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,201 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any opportunities to volunteer for this clinical research?

"Data from clinicaltrials.gov demonstrates that recruitment for this trial is ongoing. It was initially posted on November 17th 2023 and the latest revision occurred a day prior, on November 16th 2023."

Answered by AI

How many participants is the trial recruiting?

"Affirmative. Clinicaltrials.gov details confirm that this clinical trial is open for recruitment and was initially published on November 17th 2023, with the most recent update being made a day prior. 240 individuals must be enrolled from 2 specified sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Florian Schroeck 2023. "Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05796375.