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Brief Title: Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules
Official Title: Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules
Study ID: NCT04182893
Brief Summary: This study through the detection of EGFRăALKăROS1ăKRASăHER2ăBARFăNTRG1 seven ctDNA and exosome RNA in the blood and alveolar lavage of lung nodules patients and heavy smoking healthy population. If the results of ctDNA test is positive, the target nodule is malignant; if the reaults of ctDNA teste is negatie but exocome RNA is positive, the target nodule is also malignant. If the results of both tests are negtive, the target nodule is recognized as benign. The purpose is study the sensitivity, specificity and diagnostic accuracy of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules. Besides, the diagnostic efficacy of different specimens including blood and alveolar lavage in the identification of benign and malignant pulmonary nodules is also studied.
Detailed Description: Pulmonary nodules are round or irregular shape lesions with a diameter of less than or equal to 3cm. 10% lung nodules will become lung cancer, and lung cancer is evolved from small nodules. Liquid biopsy is an effective and noninvasive means to assist in the early diagnosis of lung cancer, including circulating tumor cellăexosome and ctDNA detection. CtDNA is used to detect DNA fragments relesased to plasma by cracking or apoptotic tumor cells. Exosomes are derived from living cells, and researchers found that exosome nucleic acid detection of living cells may be closely related to the dynamic development of tumors. This study through the detection of EGFRăALKăROS1ăKRASăHER2ăBARFăNTRG1 seven ctDNA and exosome RNA in the blood and alveolar lavage of lung nodules patients and heavy smoking healthy population. If the results of ctDNA test is positive, the target nodule is malignant; if the reaults of ctDNA teste is negatie but exocome RNA is positive, the target nodule is also malignant. If the results of both tests are negtive, the target nodule is recognized as benign. The purpose is study the sensitivity, specificity and diagnostic accuracy of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules. Besides, the diagnostic efficacy of different specimens including blood and alveolar lavage in the identification of benign and malignant pulmonary nodules is also studied.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Shanghai Chest Hospital, Shanghai, , China
Name: Jiayuan Sun
Affiliation: Shanghai Chest Hospital
Role: STUDY_DIRECTOR