Scientific Research

NCT03181490: Multi-centers Validation of a Circulating Tumor DNA Assay to Differentiate Benign and Malignant Pulmonary Nodules Via Targeted High-throughput DNA Methylation Sequencing
Project profile

This is a prospective-specimen collection, retrospective-blinded-evaluation (ProBE) clinical study co-led by AnchorDx Medical Co. Ltd and the First Affiliated Hospital of Guangzhou Medical University with 14 clinical centers participating. By comparing the results of the pre-surgery ctDNA methylation test with the post-surgery pathological diagnosis of benign and malignant pulmonary nodules, the comprehensive diagnostic performance of the ctDNA methylation test in clinical applications was validated in terms of sensitivity and specificity.

The study was formally launched in June 2017, and enrollment of 1490 subjects were completed by February 2019. The research team have completed the development and validation of the PulmoSeek model, which was the first diagnostic tool for classifying benign and malignant pulmonary nodules based on polygene DNA methylation biomarkers in plasma. The results were published in the internationally renowned medical journal--The Journal of Clinical Investigation.

Current project status

Have completed

Cooperative partner
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