Clinical trial NCT02700659: The Cxbladder Monitoring Study
Official title: A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Carcinoma
Lead sponsor: Pacific Edge Limited
Sponsor class: INDUSTRY
First posted: 2016-03-07
Enrollment: 803
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: 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.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
Secondary outcomes:
measure: Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 ELISA Assay.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 BladderChek Assay.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: New Britain
country: United States
facility: Urology Center of Grove Hill, One Lake Street
state: Connecticut
city: Orlando
country: United States
facility: Florida Urology Associates
state: Florida
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: New Jersey
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Kingston
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College, Department of Urology
state: New York
city: New York
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Newburgh
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Hershey
country: United States
facility: Penn State Hershey Medical Center and College of Medicine
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Pacific Edge Limited
name: Paul J O'Sullivan, PhD
role: STUDY_CHAIR
References:
citation: 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.