Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay
Suspended
- Conditions
- Bladder Cancer
- Interventions
- Diagnostic Test: UriFind Bladder Cancer Assay
- Registration Number
- NCT05643690
- Lead Sponsor
- AnchorDx Medical Co. Ltd. US
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 77
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)
Exclusion Criteria
- History of urinary cancer
- Neoadjuvant therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Clinical Validation Group UriFind Bladder Cancer Assay Patients with suspected bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results)
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer Baseline To evaluate the performance of the UriFind assay relative to the patient at diagnosis (cystoscopy or surgery followed by histology).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States