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

Lung Cancer (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830619
• Other study ID #: WuhanUH2018
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: November 2021
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer (Diagnosis)
• Lung Neoplasms
• Neoplasms

Intervention

Diagnostic Test:
• collect samples
collect serum samples and clinical features

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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