Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Nodule, Solitary
- Sponsor
- Jiayuan Sun
- Enrollment
- 401
- Locations
- 1
- Primary Endpoint
- The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Jiayuan Sun
Chief Physician, Department of Pulmonary Medicine, Director, Department of Respiratory Endoscopy and Interventional Pulmonology
Shanghai Chest Hospital
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria:
- •Aged 40-80;
- •Lung nodules were detected by CT (≥5mm，≤3cm);
- •Patients fully understand the informed consent and can sign the informed consent in person.
Exclusion Criteria
- •Exclusion criteria:
- •Patients diagnosed with malignant tumors in the past;
- •This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement；
- •Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies；
- •Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.
- •The researchers concluded that there were other conditions that made it inappropriate to participate in this study
Outcomes
Primary Outcomes
The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules
Time Frame: 12 months
The sensitivity, specificity, positive predictive value, negative predictive value and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules .