CompletedNot Applicable

Efficacy and Utility of Cxbladder Tests in Hematuria Patients

United States682 participantsStarted 2019-11-08

Plain-language summary

Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma. * Able to provide a voided urine sample of the required minimum volume * Able to give written consent * Able and willing to comply with study requirements * Aged 18 years or older Exclusion Criteria: * Prior history of bladder malignancy, prostate or renal cell carcinoma * Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection * Previous alkylating based chemotherapy * Known Pregnancy.

What they're measuring

Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.

Timeframe: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months)

Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.

Timeframe: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).

Trial details

NCT IDNCT04943380

SponsorPacific Edge Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-01-18

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