Brief Title
Efficacy and Utility of Cxbladder Tests in Hematuria Patients
Official Title
An Observational Study of Efficacy and Utility of Cxbladder Tests in the Identification of Low vs High Risk Patients and the Detection of Urothelial Carcinoma in Patients Presenting With Hematuria
Brief Summary
Prospective observational study to validate the performance characteristics and clinical
utility of Cxbladder tests in a Veterans Affairs cohort.
Detailed Description
Non-invasive, voided urine sample used for both Cxbladder molecular tests, voided urine
sample may be used for standard of care testing. Retrospective analysis of data after study
completion ensures a de-phasing of study sample analysis from clinical decision making;
patient treatment and management.
Multi-site recruitment of patients in Veterans Affairs.Target number of participants up to
four sites is around 450 sequentially recruited patients presenting for assessment of
hematuria (microscopic or macroscopic) by cystoscopy.
Study Type
Interventional
Primary Outcome
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
Secondary Outcome
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
Condition
Hematuria
Intervention
Cxbladder
Study Arms / Comparison Groups
patients with hematuria undergoing investigation for UC
Description: Patients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria. Microscopic hematuria is defined as > 3 red blood cells per high-powered microscopy field for a properly collected urine sample.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
450
Start Date
November 8, 2019
Completion Date
December 2022
Primary Completion Date
December 2022
Eligibility Criteria
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
- History of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent
history of pyelonephritis
- Previous alkylating based chemotherapy
- Pregnancy.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Tony Lough, PhD, (612) 467-5601, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04943380
Organization ID
CXB/2019/VA
Responsible Party
Sponsor
Study Sponsor
Pacific Edge Limited
Study Sponsor
Tony Lough, PhD, Study Chair, Pacific Edge Pty Ltd
Verification Date
June 2021