Bladder EpiCheck European Haematuria Study

Not yet recruiting

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

• Registration Number: NCT06818136
• Lead Sponsor: Nucleix Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-04
• Primary Completion: 2026-02
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma	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).

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom