Bladder EpiCheck European Haematuria Study

Nucleix

Status: Enrolling

Conditions: Hematuria; Cystoscopy; Urothelial Carcinoma Bladder; Urothelial Carcinoma of the Renal Pelvis and Ureter; Urothelial Carcinoma of the Urinary Bladder

Treatments: Diagnostic Test: Bladder EpiCheck

Study type: Observational

Funder types: Industry

Identifiers

NCT06818136

68096

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 1 patient group

aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma

Description:

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.

Treatment:

Diagnostic Test: Bladder EpiCheck