Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay

AnchorDx Medical Co. Ltd. US77 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bladder Cancer

Interventions

UriFind Bladder Cancer AssayDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: Clinical Validation Group: 1. 55 years or older, gender is not limited 2. Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral resection of bladder tumor (TUBRT) 3. Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis 4. Can provide at least of 75 ml of urine (prior to cystoscopy or surgery) Exclusion Criteria: 1. History of urinary cancer 2. Neoadjuvant therapy

Locations (2)

Arkansas Urology

Little Rock, Arkansas, United States

Idaho Urologic Institute

Meridian, Idaho, United States

Outcomes

Primary Outcomes

Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer

To evaluate the performance of the UriFind assay relative to the patient at diagnosis (cystoscopy or surgery followed by histology).

Time frame: Baseline

Data from ClinicalTrials.gov

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