Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule

Jiayuan Sun

Status: Completed

Conditions: Pulmonary Nodule, Solitary

Treatments: Procedure: plasma cfDNA methylation

Study type: Observational

Funder types: Other

Identifiers

NCT03989219

SHCHE201802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 401 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

401 participants in 1 patient group

lung nodules were found by CT scanning

Description:

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.

Treatment:

Procedure: plasma cfDNA methylation