Status:
WITHDRAWN
Detection of Disease in the Upper Tract
Lead Sponsor:
Pacific Edge Limited
Conditions:
Upper Tract Urinary Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
An observational study of Cxbladder performance for detection or rule-out of upper tract urothelial cancer. Subjects will be prospectively recruited to a single arm observational study to validate the...
Detailed Description
This is a single arm observational study prospectively recruiting eligible subjects with no apparent UC of the bladder following white light cystoscopy who have positive or suspicious urine cytology o...
Eligibility Criteria
Inclusion
- Suspected to have UTUC following negative cystoscopy but positive or suspicious imaging and/or urine cytology.
- Under surveillance for UTUC following a previous confirmed diagnosis of UTUC
- Able to provide a voided urine sample of the required 30 ml minimum volume
- Able to give written consent
- Able and willing to comply with study requirement
- Aged 18 years or older
Exclusion
- Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
- Total cystectomy of the bladder with bowel urinary diversion
- Pregnancy
Key Trial Info
Start Date :
November 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05349812
Start Date
November 1 2022
End Date
December 1 2023
Last Update
April 9 2024
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