The Cxbladder Monitoring Study

March 2, 2020 updated by: Pacific Edge Limited

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

803

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
    • Connecticut
      • New Britain, Connecticut, United States, 06052
        • Urology Center of Grove Hill, One Lake Street
    • Florida
      • Orlando, Florida, United States, 32803
        • Florida Urology Associates
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute
    • New Jersey
      • New Jersey, New Jersey, United States, 08054
        • Delaware Valley Urology, LLC
    • New York
      • Kingston, New York, United States, 12401
        • Premier Medical Group of the Hudson Valley
      • New York, New York, United States, 10065
        • Weill Cornell Medical College, Department of Urology
      • New York, New York, United States, 12061
        • Premier Medical Group of the Hudson Valley
      • Newburgh, New York, United States, 12550
        • Premier Medical Group of the Hudson Valley
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center and College of Medicine
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
Time Frame: The outcome measure will be assessed by 6 months after trial completion.
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.
Time Frame: The outcome measure will be assessed by 6 months after trial completion.
The outcome measure will be assessed by 6 months after trial completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
Time Frame: The outcome measure will be assessed by 6 months after trial completion.
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.
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 ELISA Assay.
Time Frame: The outcome measure will be assessed by 6 months after trial completion.
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.
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 BladderChek Assay.
Time Frame: The outcome measure will be assessed by 6 months after trial completion.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Edge Limited

Investigators

  • Study Chair: Paul J O'Sullivan, PhD, Pacific Edge Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2013

Primary Completion (Actual)

September 23, 2016

Study Completion (Actual)

September 23, 2016

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cxb-012-EXP-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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