NCT03181490

Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,490 (actual)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules. In previous studies, the investigators had taken the approach of methylation profiling by high throughput bisulfite DNA sequencing in tissue samples to identify specific methylation signatures. The investigators had learned methylation patterns that differentiate malignant vs. benign lesions from tissue samples by in-depth data mining, and then used pattern matching to classify plasma samples. In this study, the investigators are going to validate the efficacy of ctDNA methylation test for diagnosing early lung cancer by comparing results of the pre-surgery ctDNA methylation test with the post-surgery pathology.

Detailed description

This is a prospective, multi-center, observational cohort study and seeks to enroll 1230 participants with pulmonary nodules 5-30mm in diameter. The assay analyzes the ctDNA methylation profiles of lung cancer-specific biomarkers non-invasively using whole blood specimens collected before invasive surgery. The performance characteristics(sensitivity and specificity) of the pre-surgery ctDNA methylation test for detection of early lung cancer is evaluated in comparison to post-surgery pathology.

Conditions

• Pulmonary Nodule, Solitary

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Circulating Tumor DNA Methylation Test	Methylation profiling by high-throughput bisulfite DNA sequencing in blood sample to differentiate benign and malignant pulmonary nodules

Timeline

• Start date: 2017-06-08
• Primary completion: 2019-02-28
• Completion: 2019-05-31
• First posted: 2017-06-08
• Last updated: 2020-04-02

Locations

14 sites across 1 country: China