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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nucleix Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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