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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plasma cfDNA methylation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules | 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 . | 12 months |
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Inclusion Criteria:
1. Inclusion criteria:
Exclusion Criteria:
2. Exclusion criteria:
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The population of this study are those who meet the inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, PhD | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39146624 | Derived | Li Y, Xie F, Zheng Q, Zhang Y, Li W, Xu M, He Q, Li Y, Sun J. Non-invasive diagnosis of pulmonary nodules by circulating tumor DNA methylation: A prospective multicenter study. Lung Cancer. 2024 Sep;195:107930. doi: 10.1016/j.lungcan.2024.107930. Epub 2024 Aug 11. |
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Total cfDNA was extracted from 10ml plasma.
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