Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule

Completed

• Conditions: Pulmonary Nodule, Solitary
• Interventions: Procedure: plasma cfDNA methylation

• Registration Number: NCT03989219
• Lead Sponsor: Jiayuan Sun

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.

Study Timeline

• Study Start: 2018-08-15
• Study First Submitted: 2019-06-16
• Study First Submitted QC: 2019-06-16
• Study First Posted: 2019-06-18
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

• 1. Inclusion criteria:

  2. Aged 40-80;

  3. Lung nodules were detected by CT (≥5mm，≤3cm);

  4. Patients fully understand the informed consent and can sign the informed consent in person.

Exclusion Criteria

• 2. Exclusion criteria:

  3. Patients diagnosed with malignant tumors in the past;

  4. This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement；

  5. Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies；

  6. Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.

  7. The researchers concluded that there were other conditions that made it inappropriate to participate in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lung nodules were found by CT scanning	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.

Primary Outcome Measures

Name	Time	Method
The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules	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 .

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China