WithdrawnNot Applicable

Detection of Disease in the Upper Tract

Stopped: Sponsor focusing on completion of other studies at this time.

0Started 2022-11

Plain-language 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 performance characteristics of Cxbladder for suspected (UTUC) or for patients with a history of UTUC and are under surveillance for recurrence of disease.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Performance of Cxbladder for the detection of Upper Tract Urothelial Carcinoma (UTUC)

Timeframe: Up to 36 months

Trial details

NCT IDNCT05349812

SponsorPacific Edge Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Upper Tract Urinary Carcinoma trials