Urothelial CarcinomaNCT02700659
The Cxbladder Monitoring Study
An observational study of Urothelial Carcinoma, run by Pacific Edge Limited at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Cxbladder
- How many people
- 803 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Feb 2013to 23 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
UT Southwestern Medical Center
Dallas, Texas, 75390
Penn State Hershey Medical Center and College of Medicine
Hershey, Pennsylvania, 17033
Urology Centers of Alabama
Homewood, Alabama, 35209
Premier Medical Group of the Hudson Valley
Kingston, New York, 12401
Idaho Urologic Institute
Meridian, Idaho, 83642
Urology Center of Grove Hill, One Lake Street
New Britain, Connecticut, 06052
Delaware Valley Urology, LLC
New Jersey, New Jersey, 08054
Weill Cornell Medical College, Department of Urology
New York, New York, 10065
Premier Medical Group of the Hudson Valley
New York, New York, 12061
Premier Medical Group of the Hudson Valley
Newburgh, New York, 12550
Florida Urology Associates
Orlando, Florida, 32803
About this study
Official title: 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.
- Conditions
- Urothelial Carcinoma
- Being tested
- Cxbladder
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CxbladderOther
Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cxbladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: The outcome measure will be assessed by 6 months after trial completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start4 Feb 2013
- Primary completion23 Sep 2016
- Study completion23 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Edge Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul J O'Sullivan, PhD, Study chair, Pacific Edge Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700659
- Sponsor's protocol ID
- Cxb-012-EXP-013
- Status last verified
- Mar 2020
- First submitted
- 13 Jan 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32700139
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)
- ClinicalTrials.gov ID
- NCT02700659
- Acronym / sponsor ID
- Cxb-012-EXP-013
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Pacific Edge LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2013 (actual)
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 23 Sep 2016 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC monitoring patients | – | Other: CxbladderPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CxbladderCxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma. | Other | UC monitoring patients |
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.
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 32700139Lough 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J O'Sullivan, PhD study chair
Pacific Edge Limited
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Pacific Edge Limited at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: The outcome measure will be assessed by 6 months after trial completion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.