Non-Invasive ctDNA Methylation Detection for Lung Nodule Patients

Status Recruiting

Clinical Trial Summary

Low-dose computed tomography (LDCT) is recommended for early-stage lung cancer screening. However, it is often difficult to determine indolent lesions from more aggressive tumors without an invasive intervention or prolonged follow-up period. Thus, the main purpose of this study is to develop a non-invasive method to detect lung-cancer specific circulating tumor DNA (ctDNA) in blood, which can greatly improve the specificity of lung cancer early screening.

Clinical Trial Description

In this study, the investigators sought to explore sensitive and specific methylation biomarkers that are highly prevalent in lung cancer. It is the first time to perform screening assay on healthy, lung nodule, and lung cancer tissues to identify preliminary set of highly prevalent methylation markers, and then refined these markers by removing regions were unstable in matched plasma samples. Next, investigators interrogated significant methylation marker regions enriched in lung nodules of training sample set to buildup a non-invasive biomarker classification model to discriminate cancerous nodules from benign lesions. Eventually, the model in patient lung nodule samples were validated. ;

Study Design

Related Conditions & MeSH terms

Lung Nodule

Clinical Trial Details

NCT number	NCT03685669
Study type	Observational
Source	Shanghai Chest Hospital
Contact	Liu Ruijun, MD
Phone	13917200418
Email	iamliuruijun@126.com
Status	Recruiting
Phase
Start date	June 1, 2017
Completion date	December 2019

View Details

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