Clinical trial NCT05080998: CxBladder Surveillance of Intermediate and High-Risk Bladder Cancer Patients
Official title: An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Intermediate and High-Risk Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Bladder Cancer
Keywords: Recurrence
Lead sponsor: Pacific Edge Limited
Sponsor class: INDUSTRY
First posted: 2021-10-18
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will recruit intermediate and high-risk surveillance subjects (defined as per AUA/SUP Guidelines 2016, amendment 2020), previously diagnosed with urothelial carcinoma.

Brief summary: 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 positive with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of urothelial carcinoma presenting to qualified sites. To test the pathway multiple consecutive urine samples will be collected during the course of surveillance and records review follow-up will also be completed.

Detailed description: 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 and clinical utility of CxBladder Monitor test (CxbM). The study will recruit 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 strength of the proposed design is that subjects with primary or recurrence of UC can be recruited. This means, for some subjects, that there may be a range of surveillance visits prior to enrolment. A voided urine sample will be collected from each enrolled subject at each of 4 successive surveillance visits. Records review will occur 12, 24 and 48 months after the final urine sample is collected. The collected urine will be used for CxBladder testing and central urine cytology. The study will collect primary tumour tissue from the first (primary) tumour and also from the most recent recurrence, if any, in order to genotype each tumour using RNA or DNA markers indicative of an elevated risk of UC. CxBladder results will not be reported to patients or physicians. The objective of this study is to evaluate a new proposed pathway over a period of up to four visits where CxbM is alternated with cystoscopy at consecutive visits for intermediate and high-risk surveillance subjects. The new proposed pathway will be compared directly to standard of care. Analysis of data will include determining the proportion of subjects that are positive by surveillance cystoscopy (standard of care) following a negative diagnosis at the previous visit. Using the same dataset, analysis of data will include determining the proportion of subjects that are positive by surveillance cystoscopy (standard of care) following a negative CxBladder result at the previous visit. Analysis will include assessment of the theoretical possible reduction in cystoscopy procedure use associated with the new pathway. 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).

Eligibility criteria: Inclusion Criteria:

1. High and intermediate risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma
2. Subjects must agree to 4 successive visits including urine sample collection at each of the study visits and records review follow-up
3. Able to provide a voided urine sample (a sample from catheterization is not eligible) of the required minimum volume
4. Able to give written consent
5. Able and willing to comply with study requirements
6. Aged 18 years or older

Exclusion Criteria:

1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterization, urethral dilation) in the 14 days before urine collection
2. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
3. Previous muscle invasive bladder tumour (pT2 or greater)
4. Pregnancy

Primary outcomes:
measure: To determine the proposed pathway failure rate versus the standard of care failure rate.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veteran's Hospital
state: Florida
city: Charleston
country: United States
facility: Ralph H. Johnson VA Health Care System
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: White River Junction
country: United States
facility: White River Junction Veterans Affair Medical Center
state: Vermont
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Clayton
country: Australia
facility: Monash Health - Moorabbin Hospital
state: Victoria
Study officials:
affiliation: Pacific Edge Pty Ltd
name: Tony Lough
role: STUDY_CHAIR
References: