CxBladder Test for Bladder Cancer

(LOBSTER Trial)

Recruiting at 6 trial locations

Overseen By Alexis White

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pacific Edge Limited

Disqualifiers: Cystectomy, Muscle invasive tumor, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a urine test called CxBladder Monitor can reduce the need for frequent invasive procedures to check for bladder cancer recurrence. It targets individuals who have had urothelial carcinoma (UC) within the last three years and are currently monitored for cancer recurrence. Participants will provide multiple urine samples over time to evaluate the test's effectiveness. This study may suit those managing UC and comfortable with regular urine tests. As a Phase 2 trial, the research focuses on assessing the test's effectiveness in an initial, smaller group, providing an opportunity to contribute to early-stage treatment evaluation.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CxBladder test is safe for use in UC surveillance?

Research shows that the CxBladder Monitor is a simple test that detects bladder cancer using urine samples. It identifies specific substances in the urine that indicate the likelihood of cancer recurrence.

The test has proven accurate and reliable, particularly for patients at low risk who might not require frequent bladder checks with a camera (cystoscopies). The CxBladder Monitor is safe, requiring only a urine sample, which makes it easy for patients to use.

Studies have not reported any negative side effects from the CxBladder Monitor. It effectively reduces the need for invasive procedures like cystoscopies for low-risk patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CxBladder Monitor because it offers a non-invasive way to detect bladder cancer recurrence. Unlike traditional surveillance methods like cystoscopy, which involves inserting a camera into the bladder, CxBladder uses a simple urine test to identify biomarkers associated with bladder cancer. This new approach not only reduces discomfort for patients but also allows for more frequent monitoring, potentially catching recurrences earlier. By improving the ease and frequency of testing, CxBladder could lead to better outcomes for patients with bladder cancer.

What evidence suggests that the CxBladder test is effective for detecting recurrence of urothelial carcinoma?

Research shows that the CxBladder Monitor, used by participants in this trial, effectively detects bladder cancer recurrence. It has a negative predictive value of over 95%, confirming with high accuracy when cancer is not present. Studies have found that the CxBladder Monitor significantly reduces the need for frequent cystoscopies, invasive procedures for checking cancer recurrence. It has outperformed other FDA-approved urine tests for managing bladder cancer. Additionally, using CxBladder can lower the overall costs of monitoring bladder cancer over five years. Overall, evidence suggests that the CxBladder Monitor is a reliable tool for tracking bladder cancer recurrence. ^{2 4 6 7 8}

Who Is on the Research Team?

Tony Lough

Principal Investigator

Pacific Edge Pty Ltd

Are You a Good Fit for This Trial?

Inclusion Criteria

I was diagnosed with or had a recurrence of bladder cancer in the last 3 years.

I agree to attend 4 study visits and provide urine samples each time.

I can provide a urine sample on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surveillance

Participants undergo a schedule of surveillance cystoscopies and CxBladder urine diagnostic testing for recurrence of urothelial carcinoma

12 months

4 visits (in-person)

Follow-up

Records review follow-up to monitor for recurrence and evaluate the performance of the CxBladder test

48 months

3 visits (records review at 12, 24, and 48 months)

What Are the Treatments Tested in This Trial?

Interventions

• CxBladder Monitor

How Is the Trial Designed?

Group I: Single arm - Patients undergoing surveillance for UC recurrence Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Pacific Edge Limited

Lead Sponsor

Trials

8

Recruited

4,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930626/

Validation of Cxbladder® Triage and Monitor as an Adjunct ... A combined 236 patients were recruited (CxbT = 134, CxbM = 102) with results showing excellent negative predictive value of 96.43% and 95.16%, ...

2. cxbladder.com cxbladder.com/us/news/2024/real-world-evidence-for-cxbladder-to-feature-at-wsaua/

Real World Evidence for Cxbladder to Feature at WSAUA The results show that Cxbladder Monitor could reduce the total five-year surveillance costs by US$68,621 per 100 patients compared to SoC with total costs ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1078143923000091

Cxbladder Monitor testing to reduce cystoscopy frequency ... Results. During the study period, 92 patients received CxM and did not differ in demographics nor history of smoking/radiation between sites. 9 of 24 (37.5%) ...

4. mdpi.com mdpi.com/2075-4418/14/18/2061

Analytical Validation of Cxbladder® Detect, Triage, and ... Conclusions: Cxbladder accurately and reproducibly detects UC biomarker expression and can aid clinicians in risk stratification of hematuria ...

5. cxbladder.com cxbladder.com/us/news/2017/cxbladder-monitor-significantly-outperforms-fda-approved-urine-tests-for-bladder-cancer/

Cxbladder Monitor Significantly Outperforms FDA ... As stated in the paper Cxbladder Monitor 'significantly out performs current FDA approved urine tests used in the management of bladder cancer'.

6. cxbladder.com cxbladder.com/us/clinical-resources/publications/

Clinical Publications | Cxbladder NZ Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Diagnostics. 2024; 14(18):2061.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03673202

The Cxbladder Rule-out of Recurrent Urothelial Carcinoma Cxbladder Monitor is a non-invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with ...

8. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39367&ver=28&keyword=Cxbladder&keywordType=starts&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1

LCD - Genetic Testing in Oncology: Specific Tests (L39367) Cxbladder tests are prognostic in that they do not diagnose cancer but rather provide the likelihood that cancer is present in the patient. Cxbladder tests all ...