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

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

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 Overview

• Status: Suspended
• Conditions: Bladder Cancer
• Intervention / Treatment: Diagnostic test: UriFind Bladder Cancer Assay

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Idaho Urologic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The clinical validation group is to assess the safety and effectiveness of the AnchorDx UriFind™ Bladder Cancer Assay in an intended use population to establish the expected performance in the product labeling. The study also aims to provide performance evidence of the AnchorDx UriFind™ Bladder Cancer Assay in adequate number of early-stage and low-grade cases.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clinical Validation Group; Patients with suspected bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AnchorDx Medical Co. Ltd. US
• Collaborators: AnchorDx Medical Co., Ltd.; Specialty Networks
• Investigators: Study Director: Jianbing Fan, Ph.D, AnchorDx Medical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: UriFind US-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No