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

NCT05643690 | Suspended FDA Device

• 1 other identifier: UriFind US-001
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Clinical Validation Group

Patients with suspected bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results)

Diagnostic Test: UriFind Bladder Cancer Assay

Interventions

UriFind Bladder Cancer Assay DIAGNOSTIC_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.

Clinical Validation Group

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinical Validation Group:
• 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)

You may not qualify if:

• History of urinary cancer
• Neoadjuvant therapy

Sponsors & Collaborators

• AnchorDx Medical Co. Ltd. US: lead
• AnchorDx Medical Co., Ltd.: collaborator
• Specialty Networks: collaborator

Study Sites (2)

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

Idaho Urologic Institute

Meridian, Idaho, 83642, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jianbing Fan, Ph.D

  AnchorDx Medical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 9, 2022
• Study Start: November 18, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)