Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-29

Study Completion Date

2027-03-31

Brief Summary

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This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria. One of them is bladder cancer. While bladder cancer is one of the biggest worries, it is only found in few of these patients.

Most microhematuria patients will have a cystoscopy to look inside the bladder. During a cystoscopy, a small camera is inserted into the bladder. This is done through the urethra, the tube that passes urine from the bladder to the outside. In some patients it can cause pain or anxiety. Not all patients have a cystoscopy. Those that don't, usually return for a urine sample within 6 months. This is done to check if there is still blood in their urine.

This study is conducted to find out if the use of "Cxbladder Triage Plus" changes the number of cystoscopies in microhematuria patients. Cxbladder Triage Plus is also called "Triage Plus". It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder. Urothelial carcinoma is by far the most common type of bladder cancer. For the test, the patient voids some urine into a cup. A laboratory then checks the urine of specific genetic material. Abnormalities can be a sign of urothelial carcinoma. The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients.

The study is done to find out how Triage Plus changes the number of cystoscopies. Study participants first void urine into a cup. The urine is used for the Triage Plus test. The patients are then assigned to one of two groups. The assignment is random. This means the nobody can influence the assignment. The chance to be assigned to either group is the same. In the test group, the urologist will receive the Triage Plus result and discuss it with the patient. Together they decide whether to do a cystoscopy. In the control group, the urologist will not receive the Triage Plus result. The patient will also not get the result. The urologist and patient will follow standard of care to decide whether to do a cystoscopy.

For test group patients, the study gives a recommendation whether to proceed with cystoscopy. It is based on the patient's Triage Plus result. The urologist and patient do not need to follow the recommendation. If the urologist does not follow it, they will complete a survey. The survey has only one question. It is asking for the reasons of the decision.

After making their decision, patients will follow the chosen pathway. Data on the performed procedures are collected. The diagnosis will also be documented. Data will be collected for up to about 9 months.

To see how Triage Plus changes the number of cystoscopies, these will be counted in each group and then compared.

Detailed Description

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Conditions

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Hematuria - Cause Not Known

Keywords

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microscopic hematuria microhematuria urothelial carcinoma bladder cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Test Arm

The site will receive the Cxbladder Detect+ result and the urologist study investigator discuss it with the patient before making a shared decision whether or not to proceed with cystoscopy.

Group Type EXPERIMENTAL

Cxbladder Triage Plus

Intervention Type DIAGNOSTIC_TEST

Cxbladder Triage Plus is a lab developed, test that is using RNA and DNA biomarkers in the urine to assess the likelihood of the presence of urothelial carcinoma in the bladder.

Control arm

Neither the site nor the patient will receive the Cxbladder Detect+ result. The decision whether or not to proceed with cystoscopy will be made following standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cxbladder Triage Plus

Cxbladder Triage Plus is a lab developed, test that is using RNA and DNA biomarkers in the urine to assess the likelihood of the presence of urothelial carcinoma in the bladder.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patient is referred for assessment of microhematuria (MH) with presentation confirmed by urine microscopy of 3 or more red blood cells per high powered field (RBC/HPF) (documented by the referring physician or at the investigator site) within 6-months of enrollment.
2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
3. Able to give informed, written consent.
4. Able and willing to comply with study requirements.
5. Must be 19 or the legal age of consent in the jurisdiction in which the study is taking place to 88 years of age inclusive, at the time of signing the informed consent.
6. Ability to comprehend written and spoken English sufficiently to independently follow all study procedures. Or ability to comprehend Spanish with access to an English-Spanish interpreter for all study related verbal instructions and discussions.

Exclusion Criteria

1. Prior history of bladder malignancy.
2. Prior history of upper tract UC or prostatic urethral UC.
3. Gross hematuria within the last twelve months (reported in patient's records and/or during patient's interview)
4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
5. Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with concerns for urethral stricture).
6. Cystoscopy contraindicated due to another condition or anatomy.
7. History of pelvic radiation.
8. Currently receiving systemic chemotherapy or has had systemic chemotherapy within the last 6 weeks.
9. History of schistosomiasis.
10. History of chronic (\>3 months) indwelling Foley catheter or chronic (\>3 months) bladder stones.
11. Known current pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tony Lough, PhD

Role: STUDY_CHAIR

Pacific Edge Limited

Identifier Type: -

Identifier Source: org_study_id

Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Test Arm

Cxbladder Triage Plus

Control arm

Interventions

Cxbladder Triage Plus

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pacific Edge Limited

Responsible Party

Principal Investigators

Tony Lough, PhD

Locations

Urology Centers of Alabama

Urology Associates of Mobile

Advanced Urology Institute - Daytona Beach

Urologic Specialists of Northwest Indiana

Southern Urology

Chesapeake Urology Research Associates

Summit Health

Albany MED Health System

Integrated Medical Professionals

Premier Medical Group of the Hudson Valley, P. C.

Penn State Medical Center, Urology Research

Urology Associates, P. C.

Vanderbilt University Medical Center

UT Southwestern Medical Center

University of Wisconsin-Madison

Countries

Central Contacts

Donna Smith

Tony Lough, PhD

Facility Contacts

Meredith A Sharpton, PA-C

Rita Aderholt, CCRC

Pamela R Manley

Letoya Craig

Samuel Lawindy, MD

Shawna Clemons

Michelle Ramos

Thad Bourque Dr, MD

Simone Olivier

Rian J Dickstein, MD

Alice Drew

Kelley Mauro

Adrien N Bernstein, MD

Laura Davey, CCRC

Michael Yang

Lisa Cotton, RN, BSN, CCRC

Jennifer Rose, LPN, CRC

Sneha Patel

Amy Baggett

Christian Kindred

Kristen R Scarpato, MD

Perla Lopez

Maricruz Ibarra

Rebecca Marrah

Abigail Wiedmer

Other Identifiers

CXB/2024/CREDIBLE