Bladder CancerNCT02647112
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma
A study testing Bladder EpiCheck in people with Bladder Cancer, run by Nucleix Ltd. at 6 sites in 4 countries.
Trial summary
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology. Read more about this study
- Who is it for?
- Ages 22 to 100 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Bladder EpiCheck
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Dec 2015to Dec 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma
- Has all urothelial cell carcinoma tumor resected within the past 12 months
- Has a plan for cystoscopic surveillance
Who cannot join
- Planning to undergo radical cystectomy or chemotherapy-radiation for UCC
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Netherlands3 sites
AMC Medical Center
Amsterdam
ZGT Medical Center
Hengelo
Radboud University Medical Center
Nijmegen
About this study
Official title: Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.
Read the detailed description
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.
- Conditions
- Bladder Cancer
- Being tested
- Bladder EpiCheck
- Keywords
- Bladder cancer, Urine, Methylation
- 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 EpiCheckOther
Urine test for the monitoring of bladder cancer recurrence
| Study group | Role | What they receive |
|---|---|---|
| Bladder EpiCheck | Experimental | Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology Receives: Other: Bladder EpiCheck |
| Practice of medicine | No intervention | Practice of medicine including cystoscopy and cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)
the proportion of positives that are correctly identified as such by the gold standard
Measured: Day 1
Specificity (the proportion of negatives that are correctly identified as such by the gold standard)
the proportion of negatives 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 posted6 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2020
- Study completionDec 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shmulik Adler, Study director, Nucleix Ltd.Fred Witjes, Prof., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647112
- Sponsor's protocol ID
- UC-EpiCheck-EU-01
- Status last verified
- May 2021
- First submitted
- 16 Dec 2015
- 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
- Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study
- ClinicalTrials.gov ID
- NCT02647112
- Acronym / sponsor ID
- UC-EpiCheck-EU-01
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Urine, Methylation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Nucleix Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 6 Jan 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 performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.
Detailed description
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder EpiCheck | Experimental | Other: Bladder EpiCheckUrine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology |
| Practice of medicine | No intervention | –Practice of medicine including cystoscopy and cytology |
Who may qualify
- Ages
- 22 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma
- Has all urothelial cell carcinoma tumor resected within the past 12 months
- Has a plan for cystoscopic surveillance
Key exclusion criteria (1 listed)
- Planning to undergo radical cystectomy or chemotherapy-radiation for UCC
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 EpiCheckUrine test for the monitoring of bladder cancer recurrence | Other | Bladder EpiCheck |
Primary outcome
Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)
Time frame: Day 1
the proportion of positives that are correctly identified as such by the gold standard
Specificity (the proportion of negatives that are correctly identified as such by the gold standard)
Time frame: Day 1
the proportion of negatives that are correctly identified as such by the gold standard
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 study director
Nucleix Ltd.
Fred Witjes, Prof. principal investigator
Radboud University Medical Center
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder EpiCheck in people with Bladder Cancer, run by Nucleix Ltd. at 6 sites in 4 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 3 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 6 sites in Netherlands, Germany, Israel, Spain. 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?
Sensitivity (the proportion of positives 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.