Bladder CancerNCT02700464
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
A study testing Bladder EpiCheck Urine Test and Cystoscopy and pathology in people with Bladder Cancer, run by Nucleix Ltd. at 11 sites in 2 countries.
Trial summary
Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Bladder EpiCheck Urine Test and Cystoscopy and pathology
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Sep 2016to Jul 2020
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals.
- Has had all urothelial cell carcinoma tumor resected within the past 12 months
- Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
- Able to provide legally effective informed consent
- Able to produce 45mL of urine
Who cannot join
- Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Chesapeake Urology Research Associates
Baltimore, Maryland, 21237
Cleveland Clinic
Cleveland, Ohio, 44195
The Urology Center of Colorado
Denver, Colorado, 80211
Duke University Health System
Durham, North Carolina, 27710
Urological Surgeons of Long Island
Garden City, New York, 11530
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Urology San Antonio
San Antonio, Texas, 78229
University Of Washington
Seattle, Washington, 98195-6158
Michigan Institute of Urology, P.C.
Troy, Michigan, 48084
Metro Urology
Woodbury, Minnesota, 55125
About this study
Official title: The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.
Read the detailed description
The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance.
- Conditions
- Bladder Cancer
- Being tested
- Bladder EpiCheck Urine Test, Cystoscopy and pathology
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder EpiCheck Urine TestDevice
The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer
Cystoscopy and pathologyProcedure or surgery
Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy
| Study group | Role | What they receive |
|---|---|---|
| Bladder EpiCheck Urine Test | Experimental | Bladder EpiCheck Urine Test Receives: Device: Bladder EpiCheck Urine Test |
| Gold Standard | Active comparator | Cystoscopy and pathology Receives: Procedure: Cystoscopy and pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)
Measured: Day 1
Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)
Measured: Day 1
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 startSep 2016
- Primary completionApr 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shmulik Adler, MSc, Study director, Nucleix Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700464
- Sponsor's protocol ID
- UC-EpiCheck-FDA-01
- Status last verified
- Jul 2020
- First submitted
- 24 Feb 2016
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
- ClinicalTrials.gov ID
- NCT02700464
- Acronym / sponsor ID
- UC-EpiCheck-FDA-01
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Nucleix Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Jul 2020 (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.
Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.
Detailed description
The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder EpiCheck Urine Test | Experimental | Device: Bladder EpiCheck Urine TestBladder EpiCheck Urine Test |
| Gold Standard | Active comparator | Procedure: Cystoscopy and pathologyCystoscopy and pathology |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals.
- Has had all urothelial cell carcinoma tumor resected within the past 12 months
- Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
- Able to provide legally effective informed consent
- Able to produce 45mL of urine
Key exclusion criteria (1 listed)
- Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma
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 |
|---|---|---|
| Bladder EpiCheck Urine TestThe Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer | Device | Bladder EpiCheck Urine Test |
| Cystoscopy and pathologyRoutine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy | Procedure or surgery | Gold Standard |
Primary outcome
Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)
Time frame: Day 1
Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)
Time frame: Day 1
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 May 2021.
- Individual participant dataSharing planned: No
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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.
Shmulik Adler, MSc study director
Nucleix Ltd.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder EpiCheck Urine Test and Cystoscopy and pathology in people with Bladder Cancer, run by Nucleix Ltd. at 11 sites in 2 countries.
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 5 inclusion and 1 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 May 2021. 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, Canada. 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?
Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard) (time frame: Day 1). 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?
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 May 2021.