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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| Emergency General Hospital | OTHER |
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Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned. The popularization of chest CT (electronic computed tomography) screening makes it possible to detect lung cancer early. However, the diagnosis still needs pathological evidence. It is an ideal choice to obtain pathological evidence through bronchoscope and other minimally invasive means before surgical resection. However, the positive rate of tracheoscopy is still unsatisfactory, which is related to the difficulty of traditional pathological detection in detecting small specimens obtained by tracheoscopy. Liquid biopsy technology based on methylation detection has been used in early cancer screening, but its advantages have not been fully exploited due to the low content of ctDNA (circulating tumor DNA) in the current detection samples. Therefore, through prospective clinical research, the investigators plan to combine the methylation detection technology based on "Whole genome methylation sequencing(GM-seq)" with tracheoscopy, compare the traditional pathological methods with methylation detection on the bronchoscopic samples of lung nodule subjects suspected of early lung cancer, and take the postoperative pathology as the gold standard for judging benign and malignant, to confirm the feasibility and advantages of the new technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [Training set, N=80] Benign/Malignant Pulmonary Nodule | This is a prospective training-set cohort study. A stratified case-cohort design will be used to select patients with malignant pulmonary nodules and patients with benign pulmonary nodules for analysis. All participants will receive chest CT or low-dose computed tomography (LD-CT) scanning and detection of serum tumor markers, and receive Whole-genome methylation sequencing at baseline. GM-seq will perform methylation analysis to build a prediction model for benign and malignant classification. |
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| [Verification set, N=40] Benign/Malignant Pulmonary Nodule | This is a prospective validation-set cohort study. A stratified case-cohort design was used to select patients with malignant pulmonary nodules and patients with benign pulmonary nodules for analysis. All participants will verify the benign and malignant differentiation model based on GM-seq methylation analysis, and compare the results with histopathological benign and malignant results, so as to develop a clinical benign and malignant differentiation model. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-genome Methylation Sequencing(GM-seq) | Diagnostic Test | A Whole-genome Methylation detection method, which can analyze the genome-wide, single base resolution methylation of tissue / blood samples, and is used to develop a benign and malignant classification model for Pulmonary Nodule. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the receiver operating characteristic curve (ROC) | Area under curve (AUC) of GM-seq data in discriminating malignant nodules from benign nodules. | 2 years |
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Inclusion Criteria:
Exclusion criteria:
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Subjects with pulmonary nodules suspected of early lung cancer
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhou, Doctor | Beijing Hospital | Study Chair |
| Yunzhi Zhou, Doctor | Emergency General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency general hospital | Beijing | Beijing Municipality | 100028 | China | ||
| Beijing hospital |
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| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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