HematuriaNCT06818136
Bladder EpiCheck European Haematuria Study
An observational study of Hematuria and Cystoscopy, run by Nucleix Ltd. at 5 sites in United Kingdom.
Trial summary
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hematuria, Cystoscopy, Urothelial Carcinoma Bladder
- What is being tested?
- Bladder EpiCheck
- How many people
- 800 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 20 Jun 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma
Who may be able to join
- Participants aged 45 years or older
- Participants who are willing and able to provide written informed consent and adhere to study procedures
- Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
- Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment
- Participants who are able to produce at least 10 ml of voided urine
Who cannot join
- Participants with history of urothelial cancer in the bladder and/or upper urinary tract
- Participants who had prior cystoscopy for haematuria within the past 2 years
- Participants previously enrolled in this study
- Participants treated for prostate cancer within the last 12 months
- Participants treated for kidney cancer within the last 12 months
- Participants with untreated urinary tract infection
Show all 11Show fewer
- Participants with symptomatic urinary tract stones (e.g. flank pain)
- Participants on dialysis for end stage renal failure
- Participants with a long term urinary catheter
- Pregnancy (self-reported)
- Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Admin. contact
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge
Kelly Leonard, +44 (0)1223 348442, kelly.leonard3@nhs.net
Niyati Lobo, Dr.
- Recruiting
NHS Fife
Dunfermline, Fife, KY12 OSU
Keith Boath, 01383 623623 ext. 28694, fife.rdgenericresearchteam@nhs.scot
Feras Al Jaafari, Dr.
- Recruiting
NHS Lothian
Edinburgh
Simmi George, (+44)0131 537 3269 ext. 33269, simmi.george@nhs.scot
Param Mariappan, Professor
- Recruiting
Guy's and St Thomas
London
Grainne Cullen, (44) 020 7188 5678, grainne.cullen@nhs.net
Elsie Mensah, Dr.
- Recruiting
Frimley
Surrey Quays
Alexandra Edwards, (+44) 0300 613 6779, alexandra.edwards3@nhs.net
About this study
Official title: Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed.
Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.
- Conditions
- Hematuria, Cystoscopy, Urothelial Carcinoma Bladder, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma of the Urinary Bladder
- Being tested
- Bladder EpiCheck
- Keywords
- urine test, methylation, primary detection
- Medical subject headings
- Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder EpiCheckDiagnostic test
The participant will provide a voided urine sample, which will be tested using the Bladder EpiCheck test. The clinical care team and the participant will not be informed of the result, and the standard of care will not change.
| Study group | Role | What they receive |
|---|---|---|
| aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma | Adult participants aged ≥ 45 years presenting with haematuria in the past 6 months, scheduled to undergo haematuria workup, including cystoscopy, for suspicion of urothelial carcinoma. Receives: Diagnostic Test: Bladder EpiCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma, calculated versus the Reference Standard defined by cystoscopy, imaging, and, if indicated, pathological confirmation) in participants presenting with haematuria (visible and/or non-visible).
Measured: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Secondary outcomes (3)
Non-inferiority of Bladder EpiCheck overall sensitivity vs. cytology in detection of primary urothelial carcinoma
Measured: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Non-inferiority of Bladder EpiCheck specificity vs. cytology in detection of primary urothelial carcinoma
Measured: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Further validate the sensitivity of the Bladder EpiCheck test to detect pathologically confirmed high-grade urothelial carcinoma, including HG non-muscle invasive and muscle invasive disease.
Measured: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start20 Jun 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
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 HematuriaStudies 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nucleix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS, Principal investigator, Western General Hospital, Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818136
- Sponsor's protocol ID
- 68096
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Witjes JA, Morote J, Cornel EB, Gakis G, van Valenberg FJP, Lozano F, Sternberg IA, Willemsen E, Hegemann ML, Paitan Y, Leibovitch I. Performance of the Bladder EpiCheck Methylation Test for Patients Under Surveillance for Non-muscle-invasive Bladder Cancer: Results of a Multicenter, Prospective, Blinded Clinical Trial. Eur Urol Oncol. 2018 Sep;1(4):307-313. doi: 10.1016/j.euo.2018.06.011. Epub 2018 Jul 17.
PubMed 31100252
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
- ClinicalTrials.gov ID
- NCT06818136
- Acronym / sponsor ID
- 68096
- Conditions
- Hematuria, Cystoscopy, Urothelial Carcinoma Bladder, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma of the Urinary Bladder
- Keywords
- urine test, methylation, primary detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Nucleix Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Feb 2025 (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.
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed.
Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma | – | Diagnostic Test: Bladder EpiCheckAdult participants aged ≥ 45 years presenting with haematuria in the past 6 months, scheduled to undergo haematuria workup, including cystoscopy, for suspicion of urothelial carcinoma. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma
Key inclusion criteria (5 listed)
- Participants aged 45 years or older
- Participants who are willing and able to provide written informed consent and adhere to study procedures
- Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
- Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment
- Participants who are able to produce at least 10 ml of voided urine
Key exclusion criteria (11 listed)
- Participants with history of urothelial cancer in the bladder and/or upper urinary tract
- Participants who had prior cystoscopy for haematuria within the past 2 years
- Participants previously enrolled in this study
- Participants treated for prostate cancer within the last 12 months
- Participants treated for kidney cancer within the last 12 months
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 EpiCheckThe participant will provide a voided urine sample, which will be tested using the Bladder EpiCheck test. The clinical care team and the participant will not be informed of the result, and the standard of care will not change. | Diagnostic test | aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma |
Primary outcome
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma
Time frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma, calculated versus the Reference Standard defined by cystoscopy, imaging, and, if indicated, pathological confirmation) in participants presenting with haematuria (visible and/or non-visible).
3 secondary outcomes
Non-inferiority of Bladder EpiCheck overall sensitivity vs. cytology in detection of primary urothelial carcinoma
Time frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Non-inferiority of Bladder EpiCheck specificity vs. cytology in detection of primary urothelial carcinoma
Time frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Further validate the sensitivity of the Bladder EpiCheck test to detect pathologically confirmed high-grade urothelial carcinoma, including HG non-muscle invasive and muscle invasive disease.
Time frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
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 22 Jan 2026.
- Results publication: PubMed 31100252Witjes JA, Morote J, Cornel EB, Gakis G, van Valenberg FJP, Lozano F, Sternberg IA, Willemsen E, Hegemann ML, Paitan Y, Leibovitch I. Performance of the Bladder EpiCheck Methylation Test for Patients Under Surveillance for Non-muscle-invasive Bladder Cancer: Results of a Multicenter, Prospective, Blinded Clinical Trial. Eur Urol Oncol. 2018 Sep;1(4):307-313. doi: 10.1016/j.euo.2018.06.011. Epub 2018 Jul 17.
- 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.
Admin. contact
Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS principal investigator
Western General Hospital, Edinburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematuria and Cystoscopy, run by Nucleix Ltd. at 5 sites in United Kingdom.
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 11 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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 Vered Yayon (+972-8-9161616, vered.y@nucleix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma (time frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up). 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 NCT06818136, 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 22 Jan 2026.