Clinical trial NCT06818136: Bladder EpiCheck European Haematuria Study
Official title: Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hematuria
Cystoscopy
Urothelial Carcinoma Bladder
Urothelial Carcinoma of the Renal Pelvis and Ureter
Urothelial Carcinoma of the Urinary Bladder
Keywords: urine test
methylation
primary detection
Lead sponsor: Nucleix Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 600
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma
timeFrame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Secondary outcomes:
measure: Non-inferiority of Bladder EpiCheck overall sensitivity vs. cytology in detection of primary urothelial carcinoma
timeFrame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
measure: Non-inferiority of Bladder EpiCheck specificity vs. cytology in detection of primary urothelial carcinoma
timeFrame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
measure: 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.
timeFrame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
References:
citation: 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.