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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Nodules
• Intervention / Treatment: Diagnostic test: ctDNA and Exosome Combined Detection

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Jiayuan Sun; Phone Number: +86-18017321598; Email: jysun1976@163.com

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Our study population include 2 groups: pulmonary nodules group and healthy people group.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary nodules population; We will enroll 300 pulmonary nodules penplein this study. After bronchoscopy, surgical examination or clinical follow-up, pulmonary nodules were finally diagnosed as malignant or benign.	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.
Healthy population; We will enroll 100 healthy penple in this study. After bronchoscopy, surgical examination or clinical follow-up, pulmonary nodules were finally diagnosed as malignant or benign.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Study Director: Jiayuan Sun, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 29, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: ctDNA; exosomes; bronchoalveolar lavage fluid
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: SHCHE201903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No