Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay in Subjects Suspected of Having Bladder Cancer

AnchorDx Medical Co. Ltd. US2 sites in 1 country77 target enrollmentNovember 18, 2022

ConditionsBladder Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bladder Cancer
Sponsor: AnchorDx Medical Co. Ltd. US
Enrollment: 77
Locations: 2
Primary Endpoint: Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer
Status: Suspended
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation biomarkers in urine specimens from patients 22 years or older suspected of having bladder cancer. Results from the assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.

Registry

clinicaltrials.gov

Start Date

November 18, 2022

End Date

December 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

AnchorDx Medical Co. Ltd. US

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical Validation Group:
•55 years or older, gender is not limited
•Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral resection of bladder tumor (TUBRT)
•Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis
•Can provide at least of 75 ml of urine (prior to cystoscopy or surgery)