Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis

Completed

• Conditions: Lung Cancer (Diagnosis)

• Registration Number: NCT03830619
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as a biomarker for the diagnosis of lung cancer

Detailed Description

Conventional tumor markers for non-invasive diagnosis of Lung cancer (LC) exhibit insufficient sensitivity and specificity to facilitate detection of early lung cancer (ELC). The investigators aimed to identify ELC-specific exosomal lncRNA biomarkers that are highly sensitive and stable for the non-invasive diagnosis of ELC.Hence, in the present study, exosomes from the plasma of five healthy individuals and 30 LC patients and from culture media of four human bronchial epithelial cells and four cancer cells were isolated. Exosomal RNA profiling was performed using RNA sequencing to identify LC specific exosomal lncRNAs.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-02-02
• Study First Posted: 2019-02-05
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Subjects are willing to sign the informed consent form;
• Normal subjects have no evidence of any disease;
• Lung cancer patients are 18 to 75 years old, diagnosed as lung cancer by histopathology or cytopathology

Exclusion Criteria

• People are unwilling to sign the informed consent form;
• Patients with heart disease, rheumatic disease, allergic disease, COPD, pulmonary fibrosis, diabetes, thyroid disease, liver, kidney, brain disease and hematopoietic system disease;
• Pregnant or lactating women;
• Patients did not cooperate or participate in other clinical trials

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the CT scans of the lung for the patients	the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
The expression levels of serum exosome long non-coding RNA	the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
the expression levels of tumor biomarkers such as CEA, NSE, SCC, CYFR2A-1	the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China