Pulmonary Nodules Clinical Trial
Official title:
Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules
This study through the detection of EGFR、ALK、ROS1、KRAS、HER2、BARF、NTRG1 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.
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 cell、exosome 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 EGFR、ALK、ROS1、KRAS、HER2、BARF、NTRG1 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.
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