Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2025-06-20
2026-04-30
Brief Summary
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Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
45 Years
ALL
No
Sponsors
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Nucleix Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS
Role: PRINCIPAL_INVESTIGATOR
Western General Hospital, Edinburgh
Locations
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NHS Fife
Dunfermline, Fife, United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Keith Boath
Role: primary
Heather McVicars
Role: primary
References
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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.
Other Identifiers
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68096
Identifier Type: -
Identifier Source: org_study_id