KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)

NCT05680077 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1116

Last updated 2024-02-13

No results posted yet for this study

Summary

The goal of this observational study is to test the clinical efficacy of "KCNA3 and OTOP2 gene methylation combined detection kit (fluorescence PCR method)"in esophageal cancer and high-grade esophageal neoplasia auxiliary diagnosis.The main questions it aims to answer are:

1. How consistent are the test results of the kit with the clinical reference diagnostic criteria?
2. Sanger sequencing can visually show whether each sample contains methylation sites, so in this clinical trial, the kit results were compared with Sanger sequencing results to analyze the reagent's accuracy in detecting KCNA3 and OTOP2 gene methylation.

Each participant is required to provide no less than 10 ml of blood to complete the kit test.

Conditions

  • Esophageal Neoplasms

Interventions

DIAGNOSTIC_TEST

KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)

Blood samples from participants in both groups were collected and methylation tests were performed according to the kit instructions.

Sponsors & Collaborators

  • Changhai Hospital

    collaborator OTHER
  • Wuhan Ammunition Life-tech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Luowei Wang, MD · Changhai Hospital

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2023-08-30
Completion
2023-10-31

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 NCT05680077 on ClinicalTrials.gov