Detection of Disease in the Upper Tract

Withdrawn

• Conditions: Upper Tract Urinary Carcinoma

• Registration Number: NCT05349812
• Lead Sponsor: Pacific Edge Limited

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 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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-27
• Study Start: 2022-11
• Primary Completion: 2023-12
• Study Completion: 2023-12
• Last Update Submitted: 2024-04-07
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Suspected to have UTUC following negative cystoscopy but positive or suspicious imaging and/or urine cytology.
2. Under surveillance for UTUC following a previous confirmed diagnosis of UTUC
3. Able to provide a voided urine sample of the required 30 ml minimum volume
4. Able to give written consent
5. Able and willing to comply with study requirement
6. Aged 18 years or older

Exclusion Criteria

1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
2. Total cystectomy of the bladder with bowel urinary diversion
3. Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of Cxbladder for the detection of Upper Tract Urothelial Carcinoma (UTUC)	Up to 36 months	The number of subjects identified with UTUC by Cxbladder testing as verified by the gold standard for clinical diagnosis.