Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03989219

Enrollment

401

Registered

2019-06-18

Start date

2018-08-15

Completion date

2022-06-30

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Nodule, Solitary

Keywords

cfDNA methylation, CT follow-up, plasma, pulmonary nodule

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.

Interventions

PROCEDUREplasma 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 1\. Inclusion criteria: 1. Aged 40-80; 2. Lung nodules were detected by CT (≥5mm，≤3cm); 3. Patients fully understand the informed consent and can sign the informed consent in person.

Exclusion criteria

* 2\.

Design outcomes

Primary

Measure	Time frame	Description
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 .

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026