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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

Must not have

Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture)

Inability to provide a voided urine sample

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I can give my consent in English or Spanish.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo cystoscopy due to issues with my urethra.

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I cannot provide a urine sample on my own.

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I have had surgery to change the way my urine flows.

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I have had my bladder completely removed.

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I have had a bladder tumor that grew into the muscle.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met