A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China

NCT05337189 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 482

Last updated 2025-02-13

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose bladder cancer by comparing with clinical standard method (includes medical imaging (MRI, CT, etc.), cystoscopy, pathological examination).

Conditions

Interventions

DIAGNOSTIC_TEST

Urine DNA methylation analysis

Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)

PROCEDURE

medical imaging and/or cystoscopy and/or pathological examination

Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination

Sponsors & Collaborators

  • Guangzhou Xiangkang Medical Research Co., Ltd.

    collaborator UNKNOWN
  • Creative Biosciences (Guangzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Peng Du, PhD · Peking University Cancer Hospital & Institute

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2025-04-15
Completion
2025-04-30

Countries

  • China

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 NCT05337189 on ClinicalTrials.gov