Clinical trial NCT04182893: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Nodules
Keywords: bronchoalveolar lavage fluid
ctDNA
exosomes
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population include 2 groups: pulmonary nodules group and healthy people group.

Brief summary: 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.

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 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.

Eligibility criteria: Inclusion Criteria:

Age ≥18 years old; The diameter of pulmonary lesions is 0.5-3cm in chest CT within 3 months; Healthy patients in normal control group had a smoking index ≥400; Patients who are eligible and intend to bronchoscopy.

Exclusion Criteria:

The patient received blood transfusion within 1 month； Patients suffer from autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, etc； Patients with cardiopulmonary dysfunction or other taboos, not suitable for bronchoscopy; Patients refused to participate in this clinical trial; The investigator considerates that the patient has other conditions that is unsuitable for this clinical trial.

Primary outcomes:
measure: Diagnostic efficiency of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun
role: STUDY_DIRECTOR
References: