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Brief Title: New Method to Differentiate Benign and Malignant Pulmonary Nodules.
Official Title: A New Method to Differentiate Benign and Malignant Pulmonary Nodules by Mass Spectrometry Combined With Artificial Intelligence.
Study ID: NCT06056999
Brief Summary: The goal of this observational clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (\<3cm). The main questions it aims to answer is: How to combine blood metabolomic mass spectrometry detection and artificial intelligence image analysis to establish a new model for differentiating benign and malignant pulmonary nodules. Participants will be asked provide 4 mL peripheral blood for the test.
Detailed Description: The aim of this clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) analysis. It is expected to improve the accuracy of the identification of benign and malignant pulmonary nodules. Patients with clinical suspected malignant pulmonary nodules will be included in this trial. The subjects will be divided into three group by CT image presentation: (1) pure ground-glass nodule (pGGN), (2) part-solid nodule (PSN), (3) solid nodule (SN). Peripheral blood of subjects will be collected and detected by mass spectrometry to obtain the metabolomic characterization. The classification model of each group will be constructed based on the data analysis algorithm by machine learning. The diagnostic efficacy of the new model combined with the AI image analysis system for differentiating benign and malignant pulmonary nodules will be analyzed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
China-Japan Friendship Hospital, Beijing, Beijing, China
Name: Guangying Zhu
Affiliation: China-Japan Friendship Hospital
Role: PRINCIPAL_INVESTIGATOR