Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules

Pulmonary Nodules Clinical Trial

— ctDNA  

Official title:

Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182893
• Other study ID #: SHCHE201903
• Status: Recruiting
• Start date: October 8, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2019
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun
• Phone: +86-18017321598
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodules

Intervention

Diagnostic Test:
• ctDNA and Exosome Combined Detection
Through the detection and analysis of blood and alveolar lavage fluid of 300 patients with pulmonary nodules and 100 healthy population, the diagnostic efficacy of ctDNA and exosomes combined detceion will be studied.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic efficiency of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules.	Immunohistochemical method was used in ctDNA and exosome combined detection, to detect the blood and alveolar lavage of healthy people and patients with pulmonary nodules.Using the final diagnosis as the standard, the gene mutation threshold of benign and malignant lesions were demarcated, and the differences in gene expression between different types of diseases and the differences in diagnostic rates of blood and alveolar lavage fluid were explored.	9 months