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Bladder EpiCheck European Haematuria Study | Clinical Trials | Clareo Health

RECRUITING

Bladder EpiCheck European Haematuria Study

Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria

NCT06818136•Nucleix Ltd.

View on ClinicalTrials.gov

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. Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

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)
+1 more criteria

Locations (5)

NHS Fife

Dunfermline, Fife, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

NHS Lothian

Edinburgh, United Kingdom

Guy's and St Thomas

London, United Kingdom

Frimley

Surrey Quays, United Kingdom

Key Dates

Start Date

June 20, 2025

Primary Completion Date

August 1, 2026

Completion Date

December 1, 2026

Last Updated

January 22, 2026

Enrollment

800

ESTIMATED participants

Conditions

HematuriaCystoscopyUrothelial Carcinoma BladderUrothelial Carcinoma of the Renal Pelvis and UreterUrothelial Carcinoma of the Urinary Bladder

Interventions

Bladder EpiCheck

DIAGNOSTIC_TEST

Contacts

Vered Yayon

CONTACT

+972-8-9161616 vered.y@nucleix.com

Admin.

CONTACT

info@nucleix.com

A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4

NCT07218003

Non Small Cell Lung CancerCervical Cancer+8 more

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RECRUITINGPHASE2

Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma

NCT06983210

Urothelial Carcinoma BladderUrothelial Carcinoma of the Renal Pelvis and Ureter+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bladder EpiCheck European Haematuria Study

Inclusion Criteria

Exclusion Criteria

A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4

Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma

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