The Cxbladder Monitoring Study

Urothelial Carcinoma Clinical Trial

Official title:

A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700659
• Other study ID #: Cxb-012-EXP-013
• Status: Completed
• Start date: February 4, 2013
• Est. completion date: September 23, 2016

Study information

• Verified date: March 2020
• Source: Pacific Edge Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: September 23, 2016
• Est. primary completion date: September 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Other:
• Cxbladder
Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Penn State Hershey Medical Center and College of Medicine	Hershey	Pennsylvania
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Premier Medical Group of the Hudson Valley	Kingston	New York
United States	Idaho Urologic Institute	Meridian	Idaho
United States	Urology Center of Grove Hill, One Lake Street	New Britain	Connecticut
United States	Delaware Valley Urology, LLC	New Jersey	New Jersey
United States	Premier Medical Group of the Hudson Valley	New York	New York
United States	Weill Cornell Medical College, Department of Urology	New York	New York
United States	Premier Medical Group of the Hudson Valley	Newburgh	New York
United States	Florida Urology Associates	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pacific Edge Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.	Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.	The outcome measure will be assessed by 6 months after trial completion.
Secondary	Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 ELISA Assay.	Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 ELISA, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.	The outcome measure will be assessed by 6 months after trial completion.
Secondary	Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 BladderChek Assay.	Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 BladderChek, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.	The outcome measure will be assessed by 6 months after trial completion.