NCT03685669

Non-Invasive ctDNA Methylation Detection for Lung Nodule Patients

Detection of Early-stage Lung Cancer by Using Methylation Signatures in Circulating Tumor DNA

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Lung Nodule

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-06-01
• Completion: 2019-12-01
• First posted: 2018-09-26
• Last updated: 2019-01-23

Locations

1 site across 1 country: China