At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Bladder EpiCheck (diagnostic test)
- How long the study runs
- Study runs about 18 months (dates as stated)
- About the drug or intervention
- Bladder EpiCheck — diagnostic test: The participant will provide a voided urine sample, which will be tested using the Bladder EpiCheck test.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 45 Years and over
- Who
- All
- Number of participants
- 800
- Started
- 2025-06-20
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for hematuria
- • Clinical study - 800 participants
- • 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
Who can take part?
- • Ages 45 Years and over
- • Diagnosed with hematuria
Where?
- • Dunfermline - NHS Fife
- • Cambridge - Addenbrooke's Hospital
- • Edinburgh - NHS Lothian
- • London - Guy's and St Thomas
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
HematuriaCystoscopyUrothelial Carcinoma BladderUrothelial Carcinoma of the Renal Pelvis and UreterUrothelial Carcinoma of the Urinary Bladder
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 45 Years and over
- Who can join: All genders
What the study is looking for
- ✓Participants aged 45 years or older
- ✓Participants who are willing and able to provide written agreement to take part 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 the usual treatment cystoscopy for urinary bladder examination within 60 days after...
- ✓Participants who are able to produce at least 10 ml of voided urine
Who cannot take part
- ✗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
See the full criteria
Inclusion Criteria:
1. Participants aged 45 years or older
2. Participants who are willing and able to provide written informed consent and adhere to study procedures
3. Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
4. Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment
5. Participants who are able to produce at least 10 ml of voided urine
Exclusion Criteria:
1. Participants with history of urothelial cancer in the bladder and/or upper urinary tract
2. Participants who had prior cystoscopy for haematuria within the past 2 years
3. Participants previously enrolled in this study
4. Participants treated for prostate cancer within the last 12 months
5. Participants treated for kidney cancer within the last 12 months
6. Participants with untreated urinary tract infection
7. Participants with symptomatic urinary tract stones (e.g. flank pain)
8. Participants on dialysis for end stage renal failure
9. Participants with a long term urinary catheter
10. Pregnancy (self-reported)
11. Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway
Where Is This Study? (5 UK sites)
NHS Fife
Dunfermline KY12 OSU, United Kingdom
Site contact (verified)
Feras Al Jaafari, Dr.Principal Investigator
Addenbrooke's Hospital
Cambridge, United Kingdom
Site contact (verified)
Niyati Lobo, Dr.Principal Investigator
NHS Lothian
Edinburgh, United Kingdom
Site contact (verified)
Param Mariappan, ProfessorPrincipal Investigator
Guy's and St Thomas
London, United Kingdom
Site contact (verified)
Elsie Mensah, Dr.Principal Investigator
Frimley
Surrey Quays, United Kingdom
Site contact (verified)
How to Get in Touch
Vered Yayon
Sponsor contactCONTACT
+972-8-9161616 vered.y@nucleix.com
Admin.
Sponsor contactCONTACT
info@nucleix.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01