Detection of Disease in the Upper Tract

NCT05349812 | Withdrawn

• 1 other identifier: Pacificedgedx
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Upper Tract Urinary Carcinoma

Keywords

observational upper urinary tract carcinoma hematuria

Outcome Measures

Primary Outcomes (1)

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

  The number of subjects identified with UTUC by Cxbladder testing as verified by the gold standard for clinical diagnosis.

  Up to 36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacific Edge Limited: lead

Related Publications (25)

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Biospecimen

Retention: SAMPLES WITH DNA

30mls of freshly voided urine

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 27, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 9, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share