NCT05349812

Detection of Disease in the Upper Tract

An Observational Study of Cxbladder Performance for Detection or Rule-out of Upper Tract Urothelial Cancer

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Pacific Edge Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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 or imaging results. Participants will undergo all clinical investigations as prescribed by the physician as per standard of care with addition of urine sampling to enable Cxbladder and central urine cytology testing. A mid-stream voided urine sample collected at the time of appointment will be used for Cxbladder and central urine cytology testing. Cxbladder and central cytology results will not be reported to the physician. Urine sample testing will occur at Pacific Edge Ltd laboratories (Dunedin, New Zealand). Central urine cytology will be processed by an independent testing laboratory (Southern Community Laboratories, Dunedin, New Zealand). The remainder of the urine sample will be used for dipstick analysis of Specific Gravity, Leucocytes, Nitrites, Blood, Haemoglobin, and pH. The unused portion of this sample will be used for local cytology and any other analysis as deemed clinically appropriate. Central urine cytology results are not available to physicians.

Conditions

• Upper Tract Urinary Carcinoma

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-04-27
• Last updated: 2024-04-09