AzTrials
AzTrials

Non-muscle-invasive Bladder CancerPhase 2ReplaceCystoNCT05796375

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

A Phase 2 study testing Cystoscopy, Bladder EpiCheck urine test and Xpert Bladder Cancer Monitor urine test in people with Non-muscle-invasive Bladder Cancer, run by White River Junction Veterans Affairs Medical Center at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-muscle-invasive Bladder Cancer
What is being tested?
Cystoscopy, Bladder EpiCheck urine test and Xpert Bladder Cancer Monitor urine test
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
10 sitesUnited States
Study dates
17 Nov 2023to 30 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Prabhavathi Loganathan, MS contact

802-295-9363 ext. 6914

Prabhavath.Loganathan@va.gov

Laura Jensen, MPH contact

802-280-5298

Laura.Jensen@va.gov

10 sites in 1 country

United States10 sites, 8 recruiting
  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744

    Anna Rosenblatt, 727-398-6661 ext. 17051, Anna.Rosenblatt2@va.gov

    Andrew Leone, MD

    Recruiting
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Active, not recruiting
  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Paul Cinicola, 216-286-7376, paul.cinicola@uhhospitals.org

    Juan Echeverria Serrano, 216 844 5878, Juan.Echeverria-Serrano@UHhospitals.org

    Recruiting
  • UT Southwestern Medical Center

    Dallas, Texas, 75235

    Sonobia Garrett, BSHS, Sonobia.Garrett@utsouthwestern.edu

    Yair Lotan, MD

    Recruiting
  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    ZoeFaith Caraballo-Bobea,, BA, 603-653-3528, ZoeFaith.E.Caraballo.Bobea@hitchcock.org

    Laura Tafe, MD

    Recruiting
  • VA St.Louis Healthcare System

    St Louis, Missouri, 63016

    Carley Browning, 314-652-4100 ext. 57697, Carley.Browning@va.gov

    Lewis Thomas, MD

    Recruiting
  • James A. Haley Veterans' Hospital

    Tampa, Florida, 33612

    Withdrawn
  • West Haven VA Medical Center

    West Haven, Connecticut, 06516

    Alicia Roy, 203-932-5711 ext. 3006, Alicia.Roy@va.gov

    Preston Sprenkle, MD

    Recruiting
  • VA Boston Jamaica Plains Campus

    West Roxbury, Massachusetts, 02132

    Laura MacAdam, NP, 857-407-8074, Laura.MacAdam@va.gov

    Lori Lerner, MD

    Recruiting
  • White River Junction Veterans Healthcare System

    White River Junction, Vermont, 05009

    Prabha L Loganathan, MS, 802-295-9363 ext. 6914, prabhavath.loganathan@va.gov

    Laura Jensen, MPH, 802-295-9363 ext. 6953, Laura.Jensen@va.gov

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

This is a multi-site randomized phase 2 trial including 240 patients with early-stage bladder cancer, in which patients will be randomized 1:1:1 to programmatic surveillance with the Xpert bladder cancer urine test, the Bladder EpiCheck urine test, or frequent cystoscopy. The primary outcome will be urinary quality of life measured 1 to 3 days after surveillance.

This study will have three groups, also called "arms": (1) Frequent Cystoscopy Arm, (2) Xpert Urine Test Arm, and (3) Epicheck Urine Test Arm. The aim of Frequent Cystoscopy is to detect any cancer that might have come back within the bladder by frequently inspecting the bladder. Those in the cystoscopy arm will have a cystoscopy procedure at specified time points for two years. The goal of the Xpert Urine Test arm is to detect any cancer that might have come back within the bladder, while decreasing the number of invasive cystoscopy procedures. Those in the Xpert arm will have a Xpert urine test and a check-up with a medical doctor at 6 months and 18 months, and have a cystoscopy procedure at 12 months and 24 months. The aim of the EpiCheck Urine Test arm is to detect any cancer that might have come back within the bladder, while decreasing the number of invasive cystoscopy procedures. Those in the EpiCheck Urine Test arm will have an Epicheck urine test and a check-up with a medical doctor at 6 months and 18 months and will have a cystoscopy procedure at 12 months and 24 months. The study performance period is 24 months.

Being tested
Cystoscopy, Bladder EpiCheck urine test, Xpert Bladder Cancer Monitor urine test
Keywords
Bladder, Cancer, Urology, Cystoscopy, Xpert, EpiCheck, Urine test
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CystoscopyProcedure or surgery

    Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.

  • Bladder EpiCheck urine testDiagnostic test

    The Bladder EpiCheck is a laboratory-developed test for early-stage non-muscle invasive bladder cancer. The Bladder EpiCheck test is a DNA methylation test that is run on DNA extracted from cell pellet from centrifuged urine according to Standardized Operating Procedures. The test has internal controls and a dedicated software to ensure required quality assurance processes and prompt reporting of results.

  • Xpert Bladder Cancer Monitor urine testDiagnostic test

    A 4.5 ml sample of voided urine is added to Xpert® Urine Transport Reagent, mixed, and then 4ml of treated urine are transferred to the Sample Chamber of the cartridge. In the cartridge, cells in the urine sample are captured on a filter and lysed by sonication. The released nucleic acid is eluted, mixed with dry RT-PCR reagents, and the solution is transferred to the reaction tube for RT-PCR and detection.

Study groups in NCT05796375
Study groupRoleWhat they receive
Frequent CystoscopyActive comparatorCystoscopy is conducted at 6, 12, 18, and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer
Receives: Procedure: Cystoscopy
Xpert Urine TestExperimentalXpert 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
Receives: Procedure: Cystoscopy; Diagnostic Test: Xpert Bladder Cancer Monitor urine test
EpiCheck Urine TextExperimentalEpiCheck 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.
Receives: Procedure: Cystoscopy; Diagnostic Test: Bladder EpiCheck urine test

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measuring change from baseline. Score range: 0-100. Lower score indicates higher quality of life.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start17 Nov 2023
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Health care delivery parallel trial with 1:1:1 randomization
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05796375
Sponsor's protocol ID
1732756
Other IDs
R37CA275916, 1R37CA275916-01
Acronym
ReplaceCysto
Status last verified
Sep 2026
First submitted
21 Mar 2023
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Koo K, Zubkoff L, Sirovich BE, Goodney PP, Robertson DJ, Seigne JD, Schroeck FR. The Burden of Cystoscopic Bladder Cancer Surveillance: Anxiety, Discomfort, and Patient Preferences for Decision Making. Urology. 2017 Oct;108:122-128. doi: 10.1016/j.urology.2017.07.016. Epub 2017 Jul 21.

    PubMed 28739405
  • Schroeck FR, Lynch KE, Li Z, MacKenzie TA, Han DS, Seigne JD, Robertson DJ, Sirovich B, Goodney PP. The impact of frequent cystoscopy on surgical care and cancer outcomes among patients with low-risk, non-muscle-invasive bladder cancer. Cancer. 2019 Sep 15;125(18):3147-3154. doi: 10.1002/cncr.32185. Epub 2019 May 23.

    PubMed 31120559
  • Schroeck FR, Grubb R, MacKenzie TA, Ould Ismail AA, Jensen L, Tsongalis GJ, Lotan Y. Clinical Trial Protocol for "Replace Cysto": Replacing Invasive Cystoscopy with Urine Testing for Non-muscle-invasive Bladder Cancer Surveillance-A Multicenter, Randomized, Phase 2 Healthcare Delivery Trial Comparing Quality of Life During Cancer Surveillance with Xpert Bladder Cancer Monitor or Bladder EpiCheck Urine Testing Versus Frequent Cystoscopy. Eur Urol Open Sci. 2024 Mar 21;63:19-30. doi: 10.1016/j.euros.2024.02.018. eCollection 2024 May.

    PubMed 38558761

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cystoscopy, Bladder EpiCheck urine test and Xpert Bladder Cancer Monitor urine test in people with Non-muscle-invasive Bladder Cancer, run by White River Junction Veterans Affairs Medical Center at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prabhavathi Loganathan, MS (802-295-9363 ext. 6914, Prabhavath.Loganathan@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life Questionnaire-Non-Muscle Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24) (time frame: Assessed at 3, 6, 12, 18, and 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05796375, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in