Bladder EpiCheck European Haematuria Study

NCT06818136 | Recruiting

• 1 other identifier: 68096
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cystoscopy; Urothelial Carcinoma of the Renal Pelvis and Ureter; Urothelial Carcinoma of the Urinary Bladder; Hematuria; Urothelial Carcinoma Bladder

Keywords

urine test; methylation; primary detection

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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.

  urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up

Study Arms (1)

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.

Diagnostic Test: Bladder EpiCheck

Interventions

Bladder EpiCheck DIAGNOSTIC_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.

aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nucleix Ltd.: lead

Study Sites (5)

NHS Fife

Dunfermline, Fife, KY12 OSU, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, United Kingdom

RECRUITING

NHS Lothian

Edinburgh, United Kingdom

RECRUITING

Guy's and St Thomas

London, United Kingdom

RECRUITING

Frimley

Surrey Quays, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 31100252 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

voided urine

MeSH Terms

Conditions

Hematuria

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS

  Western General Hospital, Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vered Yayon

CONTACT

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

Admin.

CONTACT

info@nucleix.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)