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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03830619
Other study ID # WuhanUH2018
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT05110131 - Evaluation of the Synergistic Impact of Needle and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy N/A
Completed NCT03633006 - Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer