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NCT05643690 Clinical Trial

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

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT05643690
Other study ID # UriFind US-001
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date November 18, 2022
Est. completion date December 31, 2025

Study information
Verified date June 2024
Source AnchorDx Medical Co. Ltd. US
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 77
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 55 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• UriFind Bladder Cancer Assay
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.

Locations
Country Name City State
United States Arkansas Urology Little Rock Arkansas
United States Idaho Urologic Institute Meridian Idaho

Sponsors (3)
Lead Sponsor Collaborator
AnchorDx Medical Co. Ltd. US AnchorDx Medical Co., Ltd., Specialty Networks

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). Baseline
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