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NCT Number: NCT06818136

Bladder EpiCheck European Haematuria Study

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.

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Key information

Conditions

Hematuria Cystoscopy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urothelial Carcinoma Bladder Urothelial Carcinoma of the Renal Pelvis and Ureter Urothelial Carcinoma of the Urinary Bladder

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Fife, Dunfermline, Fife, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Admin.

CONTACT

[email protected]

Vered Yayon

CONTACT

[email protected]

+972-8-9161616

Sponsors and collaborators

Lead sponsor

Nucleix Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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