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Longitudinal Bladder Cancer Study for Tumour Recurrence

NCT ID: NCT05080998

Last Updated: 2025-11-10

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

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-08

Study Completion Date

2026-08-31

Brief Summary

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Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.

Detailed Description

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This is a multi-site study recruiting subjects from Veterans Affairs and other medical centers. Subjects will be prospectively recruited to an observational study to validate the performance characteristics of CxBladder Monitor test (Monitor) and the second-generation test, CxBladder Monitor Plus (Monitor+). The study will recruit low, intermediate, and high-risk surveillance subjects, defined as per American Urological Association (AUA) / Society of Urologic Oncology (SUO) guidelines 2016 amendment 2020, previously diagnosed with urothelial carcinoma (UC). Eligible subjects will include those under surveillance for recurrence of UC. A voided urine sample will be collected from each enrolled subject at each of 4 successive surveillance visits. The collected urine will be used for CxBladder testing and central urine cytology. The study will collect primary tumour tissue from the first confirmed tumour, i.e., the primary diagnosis of UC (if available) and any subsequent collections within 12 weeks. Tissue samples from any UC recurrences while in study will also be collected to genotype each tumour using RNA or DNA markers indicative of an elevated risk of UC. Monitor/Monitor+ results will not be reported to patients or physicians. This study primarily aims to clinically validate the performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value, and test-negative rate) of the Cxbladder Monitor/Monitor+ test compared to the reference standard i.e., tumours observed by cystoscopy and confirmed by pathology over a maximum of 4 surveillance visits. Sites are required to be competent in recruiting and completing required test request forms, Case Report Forms (CRF) and sample collection in a professional manner in accordance with good clinical practice (GCP).

Conditions

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Urothelial Bladder Cancer

Keywords

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Recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single arm - Patients undergoing surveillance for UC recurrence

Subjects previously diagnosed with UC and are undergoing a schedule of surveillance cystoscopies and treatment for the possible recurrence of UC will be recruited. Low-, intermediate-, and high-risk groups, according to AUA /SUO risk categorisation for non-muscle invasive UC, will be eligible for this study. All subjects will undergo CxBladder urine diagnostic testing.

CxBladder Monitor/Monitor+

Intervention Type DIAGNOSTIC_TEST

CxBladder Monitor/Monitor+ is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.

Interventions

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CxBladder Monitor/Monitor+

CxBladder Monitor/Monitor+ is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.
2. Subjects must agree to 4 successive study visits, including urine sample collection at each visit.
3. Physically able to provide a voided urine sample (a sample from catheterization is not eligible).
4. Able to give written informed consent
5. Able and willing to comply with study requirements
6. Aged 18 years or older

Exclusion Criteria

1. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
2. Previous muscle invasive bladder tumour (pT2 or greater)
3. Known pregnancy

Deferral Criteria

1. Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed.
2. Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved.
3. If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pacific Edge Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tony Lough

Role: STUDY_CHAIR

Pacific Edge Pty Ltd

Locations

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Miami VA Healthcare System

Miami, Florida, United States

Site Status RECRUITING

James A. Haley Veteran's Hospital

Tampa, Florida, United States

Site Status RECRUITING

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, United States

Site Status RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

White River Junction Veterans Affair Medical Center

White River Junction, Vermont, United States

Site Status RECRUITING

University of Washington School of Medicine

Seattle, Washington, United States

Site Status RECRUITING

Monash Health - Moorabbin Hospital

Clayton, Victoria, Australia

Site Status RECRUITING

Countries

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United States Australia

Central Contacts

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Donna Smith, MSc (Hons)

Role: CONTACT

Phone: +64 21 243 6696

Email: [email protected]

Alexis White

Role: CONTACT

Phone: +64 21 959 001

Email: [email protected]

Facility Contacts

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Brittney Vail

Role: primary

Rebecca Reinhard

Role: primary

Lauren Deland

Role: backup

Penny Hukee

Role: primary

Elina Bolukbasi

Role: backup

Phillip McDuffie

Role: primary

Barbara Timian

Role: primary

Laura Jensen

Role: backup

Holly Covert

Role: primary

Nita han

Role: backup

Nandini Atul Kumar Patel

Role: primary

Sue Mosley

Role: backup

Other Identifiers

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CXBM/2021/VA

Identifier Type: -

Identifier Source: org_study_id