Suspicion of Bladder CancerNCT07514143
Bladder EpiCheck Product Development Study
An observational study of Suspicion of Bladder Cancer and NMIBC Surveillance, run by Nucleix Ltd. at 2 sites in United States.
Trial summary
This is a prospective, observational study to support the development of the Bladder EpiCheck kit by collecting urine samples from subjects suspected to have a bladder tumor or under NMIBC surveillance. This is a single visit study. Each subject will sign the informed consent and provide voided urine sample. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Suspicion of Bladder Cancer, NMIBC Surveillance
- What is being tested?
- Bladder EpiCheck
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult subjects who are planned to undergo within 60 days either TURBT, cystoscopy and anesthesia or cystoscopy without anesthesia. TURBT and cystoscopy under anesthesia should be due to detection or suspicion of bladder tumor, cystoscopy without anesthesia should be for NMIBC monitoring.
Who may be able to join
- Age 22 or older
- Willing and able to sign the informed consent form
- Subject(s) that is planned to undergo ,within 60 days, one of the following procedures:
- 3.1 TURBT due to suspected or detected bladder tumor, or 3.2 Cystoscopy under general anesthesia due to suspected bladder tumor, or 3.3 Cystoscopy for NMIBC surveillance
Who cannot join
- Patients with known or history of muscle invasive bladder cancer (MIBC)
- Treatment of prostate cancer or RCC in the past 2 years
- Patients previously enrolled into this study within the prior 60 days
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Om Research LLC
San Diego, California, 92103
Gavriushina, 858.429.7050, agavriushina@omclinicaltrials.com
- Recruiting
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Phelps, 410-205-8590, stephanie.phelps@chesuro.com
About this study
Official title: Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
This is a prospective, observational study to support the development of the Bladder EpiCheck kit by collecting urine samples from subjects suspected to have a bladder tumor or under NMIBC surveillance.
This is a single visit study. Each subject will sign the informed consent and provide voided urine sample. Demography and, if performed, pathology information will be collected for each subject.
- Conditions
- Suspicion of Bladder Cancer, NMIBC Surveillance
- Being tested
- Bladder EpiCheck
- Keywords
- EpiCheck, Bladder cancer
- 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 EpiCheckDiagnostic test
Methylation biomarker urine test
| Study group | Role | What they receive |
|---|---|---|
| Subjects planned to undergo TURBT due to suspected or detected bladder tumor | Adult subjects planned to undergo TURBT within 60 days due to suspected or detected bladder tumor (e.g., by cystoscopy, cytology, imaging) will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing. Receives: Diagnostic Test: Bladder EpiCheck | |
| Subjects planned to undergo cystoscopy under general anesthesia due to suspected bladder tumor | Adult subjects planned to undergo cystoscopy under general anesthesia ,within 60 days due to suspected bladder tumor will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing. Receives: Diagnostic Test: Bladder EpiCheck | |
| Subjects planned to undergo cystoscopy for NMIBC surveillance | Adult subjects planned to undergo cystoscopy for NMIBC surveillance ,within 60 days will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing. Receives: Diagnostic Test: Bladder EpiCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study.
The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study. For each product development protocol a pre-specified primary endpoint will be defined in a dedicated SAP. For example, validation of a new PCR platform will assess the rate of agreement between the approved PCR platform and the new new platform.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Sep 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspicion of 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nucleix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514143
- Sponsor's protocol ID
- Nucleix
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
- ClinicalTrials.gov ID
- NCT07514143
- Acronym / sponsor ID
- Nucleix
- Conditions
- Suspicion of Bladder Cancer, NMIBC Surveillance
- Keywords
- EpiCheck, Bladder cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nucleix Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Apr 2026 (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, observational study to support the development of the Bladder EpiCheck kit by collecting urine samples from subjects suspected to have a bladder tumor or under NMIBC surveillance.
This is a single visit study. Each subject will sign the informed consent and provide voided urine sample. Demography and, if performed, pathology information will be collected for each subject.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects planned to undergo TURBT due to suspected or detected bladder tumor | – | Diagnostic Test: Bladder EpiCheckAdult subjects planned to undergo TURBT within 60 days due to suspected or detected bladder tumor (e.g., by cystoscopy, cytology, imaging) will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing. |
| Subjects planned to undergo cystoscopy under general anesthesia due to suspected bladder tumor | – | Diagnostic Test: Bladder EpiCheckAdult subjects planned to undergo cystoscopy under general anesthesia ,within 60 days due to suspected bladder tumor will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing. |
| Subjects planned to undergo cystoscopy for NMIBC surveillance | – | Diagnostic Test: Bladder EpiCheckAdult subjects planned to undergo cystoscopy for NMIBC surveillance ,within 60 days will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects who are planned to undergo within 60 days either TURBT, cystoscopy and anesthesia or cystoscopy without anesthesia. TURBT and cystoscopy under anesthesia should be due to detection or suspicion of bladder tumor, cystoscopy without anesthesia should be for NMIBC monitoring.
Key inclusion criteria (4 listed)
- Age 22 or older
- Willing and able to sign the informed consent form
- Subject(s) that is planned to undergo ,within 60 days, one of the following procedures:
- 3.1 TURBT due to suspected or detected bladder tumor, or 3.2 Cystoscopy under general anesthesia due to suspected bladder tumor, or 3.3 Cystoscopy for NMIBC surveillance
Key exclusion criteria (3 listed)
- Patients with known or history of muscle invasive bladder cancer (MIBC)
- Treatment of prostate cancer or RCC in the past 2 years
- Patients previously enrolled into this study within the prior 60 days
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 EpiCheckMethylation biomarker urine test | Diagnostic test | Subjects planned to undergo TURBT due to suspected or detected bladder tumor, Subjects planned to undergo cystoscopy for NMIBC surveillance, Subjects planned to undergo cystoscopy under general anesthesia due to suspected bladder tumor |
Primary outcome
The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study.
Time frame: 1 year
The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study. For each product development protocol a pre-specified primary endpoint will be defined in a dedicated SAP. For example, validation of a new PCR platform will assess the rate of agreement between the approved PCR platform and the new new platform.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suspicion of Bladder Cancer and NMIBC Surveillance, run by Nucleix Ltd. at 2 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Limor Klein, PhD (+972-8-9161616, limor.k@nucleix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study. (time frame: 1 year). 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 Apr 2026.