The Cxbladder Monitoring Study
A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)
1 other identifier
observational
803
1 country
11
Brief Summary
The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated according to standard practice and are undergoing routine investigative cystoscopy. The gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 4, 2013
CompletedFirst Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
March 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2016
CompletedMarch 4, 2020
March 1, 2020
3.6 years
January 13, 2016
March 2, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.
The outcome measure will be assessed by 6 months after trial completion.
Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.
The outcome measure will be assessed by 6 months after trial completion.
Secondary Outcomes (3)
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
The outcome measure will be assessed by 6 months after trial completion.
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 ELISA Assay.
The outcome measure will be assessed by 6 months after trial completion.
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 BladderChek Assay.
The outcome measure will be assessed by 6 months after trial completion.
Study Arms (1)
UC monitoring patients
Patients undergoing investigative cystoscopy for the detection of urothelial carcinoma as part of a standard-of-care schedule of investigations. All patients will have urine samples taken and analyzed for NMP22 ELISA, NMP22 BladderChek, urine cytology and Cxbladder. No results for any tests under evaluation in this study are provided to the clinician for diagnostic purposes.
Interventions
Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.
Eligibility Criteria
Subjects were recruited from community and referral centres. Patients were under surveillance for recurring urothelial carcinoma monitoring, and undergoing all standard of care, including investigative cystoscopy.
You may qualify if:
- Confirmed positive diagnosis for primary or recurrent urinary tract UC over the past 2 years.
- Patient is undergoing investigative cystoscopies for the monitoring of recurrence of UC at intervals prescribed by a clinical practitioner
- Patient is 18 years of age or older.
You may not qualify if:
- Prior genitourinary manipulation (cystoscopy / catheterisation / dilation) in the 14 days before urine collection, current urinary tract infection, current or known history of urinary tract inflammatory disorder, recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
- Patient has undergone total bladder cystectomy as treatment for bladder UC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Urology Center of Grove Hill, One Lake Street
New Britain, Connecticut, 06052, United States
Florida Urology Associates
Orlando, Florida, 32803, United States
Idaho Urologic Institute
Meridian, Idaho, 83642, United States
Delaware Valley Urology, LLC
New Jersey, New Jersey, 08054, United States
Premier Medical Group of the Hudson Valley
Kingston, New York, 12401, United States
Weill Cornell Medical College, Department of Urology
New York, New York, 10065, United States
Premier Medical Group of the Hudson Valley
New York, New York, 12061, United States
Premier Medical Group of the Hudson Valley
Newburgh, New York, 12550, United States
Penn State Hershey Medical Center and College of Medicine
Hershey, Pennsylvania, 17033, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (1)
Lough T, Luo Q, O'Sullivan P, Chemasle C, Stotzer M, Suttie J, Darling D. Clinical Utility of Cxbladder Monitor for Patients with a History of Urothelial Carcinoma: A Physician-Patient Real-World Clinical Data Analysis. Oncol Ther. 2018 Jun;6(1):73-85. doi: 10.1007/s40487-018-0059-5. Epub 2018 Apr 19.
PMID: 32700139DERIVED
Biospecimen
De-identified, consented participant samples of between 5mL and 15 mL of urine, stabilized in the proprietary Cxbladder liquid, will be stored at -80ºC for further urinary diagnostic assay development and improvement.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul J O'Sullivan, PhD
Pacific Edge Limited
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2016
First Posted
March 7, 2016
Study Start
February 4, 2013
Primary Completion
September 23, 2016
Study Completion
September 23, 2016
Last Updated
March 4, 2020
Record last verified: 2020-03