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UTUC: An Observational Study of Upper Tract Urothelial Cancer

Sponsor
Pacific Edge Limited (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05349812
Collaborator
(none)
300
Enrollment
15
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study of Cxbladder Performance for Detection or Rule-out of Upper Tract Urothelial Cancer
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pacific Edge Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Pacific Edge Limited
    ClinicalTrials.gov Identifier:
    NCT05349812
    Other Study ID Numbers:
    • Pacificedgedx
    First Posted:
    Apr 27, 2022
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pacific Edge Limited
    observational upper urinary tract carcinoma hematuria
    Additional relevant MeSH terms:
    Carcinoma

    Study Results

    No Results Posted as of Apr 27, 2022