Brief Title
The Cxbladder Monitoring Study
Official Title
A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)
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.
Study Type
Observational
Primary Outcome
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
Secondary Outcome
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
Condition
Urothelial Carcinoma
Intervention
Cxbladder
Study Arms / Comparison Groups
UC monitoring patients
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
803
Start Date
February 4, 2013
Completion Date
September 23, 2016
Primary Completion Date
September 23, 2016
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paul J O'Sullivan, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02700659
Organization ID
Cxb-012-EXP-013
Responsible Party
Sponsor
Study Sponsor
Pacific Edge Limited
Study Sponsor
Paul J O'Sullivan, PhD, Study Chair, Pacific Edge Limited
Verification Date
March 2020