Clinical trial NCT05349812: Detection of Disease in the Upper Tract
Official title: An Observational Study of Cxbladder Performance for Detection or Rule-out of Upper Tract Urothelial Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Upper Tract Urinary Carcinoma
Keywords: observational upper urinary tract carcinoma hematuria
Lead sponsor: Pacific Edge Limited
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a single arm observational study prospectively recruiting eligible patients with no apparent bladder cancer following white light cystoscopy but have positive or suspicious urine cytology or imaging results.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance of Cxbladder for the detection of Upper Tract Urothelial Carcinoma (UTUC)
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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