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

NCT04182893 | Unknown

• 1 other identifier: SHCHE201903
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Nodules

Keywords

bronchoalveolar lavage fluid; ctDNA; exosomes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

ctDNA and Exosome Combined Detection DIAGNOSTIC_TEST

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; Pulmonary nodules population

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

In this study, 12ml blood was extracted before bronchoscopy and 15ml bronchoalveolar lavage fluid was collected during bronchoscopy.

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiayuan Sun

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun

CONTACT

+86-18017321598; jysun1976@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Endoscope Department,Shanghai Chest Hospital

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: December 2, 2019
• Study Start: October 8, 2019
• Primary Completion: July 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

CN (1)