Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

401 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-15

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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

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Pulmonary Nodule, Solitary

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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lung nodules were found by CT scanning

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.

plasma cfDNA methylation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

1. Patients diagnosed with malignant tumors in the past;
2. This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement；
3. Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies；
4. Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.
5. The researchers concluded that there were other conditions that made it inappropriate to participate in this study

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No