CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,116 enrolled
Drug / intervention
KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05680077
NCT05680077N/ACompleted

Methylation Detection of KCNA3 and OTOP2 Genes in Plasma for the Auxiliary Diagnosis of Esophageal Cancer/Precancerous Lesions: a Clinical Trial

Wuhan Ammunition Life-tech Co., Ltd·observational·Posted Jan 11, 2023·Updated Feb 13, 2024

In Brief

An observational study evaluating KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method) for Esophageal Neoplasms. Completed, enrolled 1,116 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
CollaboratorsChanghai Hospital

Timeline

N/ACompletedFinished
2023202420252026
First PostedJan 11, 2023
Enrollment StartOct 28, 2022
Primary CompletionAug 30, 2023
Study CompletionOct 31, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.5 years ago

Interventions

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

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