Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing

Completed

• Conditions: Lung Neoplasm; Carcinoma; Non-small-cell Lung Cancer

• Registration Number: NCT03320044
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and evaluate peripheral blood detection for identifying nature of pulmonary nodule.

Detailed Description

Early diagnosis of lung cancer is of vital importance in lung cancer treatment. This research will first analyse the features of immune repertoire and genetic mutations from tissue of benign and malignant pulmonary nodule，then explore the feasibility of detecting these features from peripheral blood sample, and finally evaluate peripheral blood detection of lung cancer related immune repertoire and genetic mutations for identifying nature of pulmonary nodule.

Study Timeline

• Study Start: 2017-10-18
• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-24
• Primary Completion: 2018-07-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Sign informed consent and consent to participate in this study;
2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion Criteria

1. Malignant tumor history within the past 5 years;
2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
3. Histology confirmed not non-small cell lung cancer
4. No matching tissue or blood samplesUnqualified blood samples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of combining peripheral plasma circulating tumor DNA and white cell immuno-sequencing in diagnosis of early stage non-small cell lung cancer	6 months

Secondary Outcome Measures

Name	Time	Method
The sensitivity and specificity of tissue immune repertoire in diagnosis of early stage non-small cell lung cancer	6 months
The concordance of peripheral plasma circulating tumor DNA and tumor tissue DNA in diagnosis of early stage non-small cell lung cancer	6 months

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China