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PENK Methylation Test for Detecting Bladder Cancer

NCT05220189 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1549

Last updated 2023-10-04

No results posted yet for this study

Summary

The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® Bladder Cancer test for bladder cancer among patients with hematuria by comparing it to the results of cystoscopy examinations.

The second objective is to compare the clinical performance of EarlyTect® Bladder Cancer test with a NMP22 test and urine cytology test with respect to bladder cancer. By histopathological examination, lesions identified during cystoscopy will be confirmed as malignant or non-malignant by histological examination.

Conditions

Interventions

DIAGNOSTIC_TEST

EarlyTect® Bladder Cancer test

A highly accurate and sensitive real-time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE-qMSP) for measuring PENK methylation in urine DNA to detect bladder cancer in hematuria patients.

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Korea University Anam Hospital

    collaborator OTHER

  • National Cancer Center, Korea

    collaborator OTHER_GOV

  • Pusan National University Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Ajou University School of Medicine

    collaborator OTHER

  • Ulsan University Hospital

    collaborator OTHER

  • Chonnam National University Hospital

    collaborator OTHER

  • Seoul Clinical Laboratories

    collaborator UNKNOWN

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Cheol Kwak, MD PhD · Seoul National University Hospital

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2023-12-31
Completion
2024-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT05220189 on ClinicalTrials.gov