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Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection

NCT04948528 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 490

Last updated 2023-05-24

No results posted yet for this study

Summary

Clinical trial to determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.

Conditions

  • Upper Tract Urothelial Carcinoma

Interventions

OTHER

Active Comparator: Surgery Pathology or Cystoscopy

Case group will be followed up with surgery pathology or cystoscopy.

OTHER

Active Comparator: Clinical Diagnosis

Control group will be diagnosed in clinical.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Peking University Third Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • AnchorDx Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jian HUANG, MD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-06-25
Completion
2023-12-31

Countries

  • China

Study Locations

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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 NCT04948528 on ClinicalTrials.gov