Bladder EpiCheck European Haematuria Study

January 21, 2026 updated by: Nucleix Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
        • Principal Investigator:
          • Niyati Lobo, Dr.
      • Edinburgh, United Kingdom
        • Recruiting
        • NHS Lothian
        • Principal Investigator:
          • Param Mariappan, Professor
        • Contact:
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas
        • Contact:
        • Principal Investigator:
          • Elsie Mensah, Dr.
      • Surrey Quays, United Kingdom
    • Fife
      • Dunfermline, Fife, United Kingdom, KY12 OSU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
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.
Time Frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nucleix Ltd.

Investigators

  • Principal Investigator: Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS, Western General Hospital, Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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