NCT03989219

Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule

Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 401 (actual)
• Sponsor: Jiayuan Sun · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules.

Detailed description

This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT. Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite pathological findings. Pulmonary nodules that temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules.

Conditions

• Pulmonary Nodule, Solitary

Interventions

Type	Name	Description
PROCEDURE	plasma cfDNA methylation	plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.

Timeline

• Start date: 2018-08-15
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2019-06-18
• Last updated: 2022-08-08

Locations

1 site across 1 country: China