Non Muscle Invasive Bladder CancerNCT06020807
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
An observational study of Non Muscle Invasive Bladder Cancer and Non-Muscle Invasive Bladder Urothelial Carcinoma, run by Nucleix Ltd. at 1 site in United States.
Trial summary
This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma
- What is being tested?
- Bladder EpiCheck
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 8 Jan 2020
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects and urology patients without prior history or evidence of bladder cancer will be recruited from urology group clinics.
Who may be able to join
- Age 22 or older
- Able to sign the informed consent form
- Normal, healthy subjects or subjects with one of the following conditions:
- Benign non-genitourinary disease (e.g. heart disease)
- Non-genitourinary cancers (e.g. lung, CRC, breast)
- Genitourinary disease other than bladder cancer including:
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- Benign prostatic hyperplasia (BPH)
- Microhematuria proven negative for bladder cancer through prior UCC evaluation
- Inflammation/infection
- Symptomatic sexually transmitted disease (STD)
- Urinary tract stones
- Genitourinary trauma
- Subjects with native bladder
Who cannot join
- Known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive)
- Currently in work-up due to suspicion of cancer of any kind
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.
- Being tested
- Bladder EpiCheck
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder EpiCheckDiagnostic test
Bladder EpiCheckTM (EpiCheck) is a urine test for monitoring of recurrence of NMIBC based on analysis of 15 informative DNA methylation biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy subjects and urology patients without prior history or evidence of bladder cancer Receives: Diagnostic Test: Bladder EpiCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity
The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.
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 posted1 Sep 2023
- Study start5 Sep 2019
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020807
- Sponsor's protocol ID
- UC-Bladder EpiCheck-FDA-02
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
- ClinicalTrials.gov ID
- NCT06020807
- Acronym / sponsor ID
- UC-Bladder EpiCheck-FDA-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Nucleix Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 1 Sep 2023 (actual)
- 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.
This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: Bladder EpiCheckHealthy subjects and urology patients without prior history or evidence of bladder cancer |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects and urology patients without prior history or evidence of bladder cancer will be recruited from urology group clinics.
Key inclusion criteria (13 listed)
- Age 22 or older
- Able to sign the informed consent form
- Normal, healthy subjects or subjects with one of the following conditions:
- Subjects with native bladder
Key exclusion criteria (2 listed)
- Known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive)
- Currently in work-up due to suspicion of cancer of any kind
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 EpiCheckBladder EpiCheckTM (EpiCheck) is a urine test for monitoring of recurrence of NMIBC based on analysis of 15 informative DNA methylation biomarkers. | Diagnostic test | Healthy |
Primary outcome
Specificity
Time frame: Day 1
The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.
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 7 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Muscle Invasive Bladder Cancer and Non-Muscle Invasive Bladder Urothelial Carcinoma, run by Nucleix Ltd. at 1 site 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 13 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Specificity (time frame: Day 1). 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 7 Sep 2023.