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RECRUITINGOBSERVATIONAL

Bladder EpiCheck European Haematuria Study

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants aged 45 years or older 2. Participants who are willing and able to provide written willing to sign a consent form 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (5)

NHS Fife
Dunfermline, Fife, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Guy's and St Thomas
London, United Kingdom
Frimley
Surrey Quays, United Kingdom