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Recruiting NCT06818136

Bladder EpiCheck European Haematuria Study

— Observational Hematuria Cystoscopy Urothelial Carcinoma Bladder Urothelial Carcinoma of the Renal Pelvis and Ureter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bladder EpiCheck.
Who it may be relevant to
Registry conditions: Hematuria, Cystoscopy, Urothelial Carcinoma Bladder, Urothelial Carcinoma of the Renal Pelvis and Ureter. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]
  • 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]
  • 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]

Eligibility criteria

Inclusion criteria

  • Participants aged 45 years or older
  • Participants who are willing and able to provide written informed consent and adhere to study procedures
  • Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
  • Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment
  • Participants who are able to produce at least 10 ml of voided urine

Exclusion criteria

  • Participants with history of urothelial cancer in the bladder and/or upper urinary tract
  • Participants who had prior cystoscopy for haematuria within the past 2 years
  • Participants previously enrolled in this study
  • Participants treated for prostate cancer within the last 12 months
  • Participants treated for kidney cancer within the last 12 months
  • Participants with untreated urinary tract infection
  • Participants with symptomatic urinary tract stones (e.g. flank pain)
  • Participants on dialysis for end stage renal failure
  • Participants with a long term urinary catheter
  • Pregnancy (self-reported)
  • Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 5 centers
  • NHS Fife — Dunfermline
  • Addenbrooke's Hospital — Cambridge
  • NHS Lothian — Edinburgh
  • Guy's and St Thomas — London
  • Frimley — Surrey Quays

Publications

  • 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 20 PMID 31100252

Identifiers

NCT: NCT06818136 · 68096

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗