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

NCT05643690 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2024-06-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • AnchorDx Medical Co., Ltd.

    collaborator INDUSTRY
  • Specialty Networks

    collaborator UNKNOWN
  • AnchorDx Medical Co. Ltd. US

    lead INDUSTRY

Principal Investigators

  • Jianbing Fan, Ph.D · AnchorDx Medical Co., Ltd.

Eligibility

Min Age
55 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05643690 on ClinicalTrials.gov