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

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Completed
CT.gov ID
NCT03830619
Collaborator
(none)
1,000
1
54.9
18.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: collect samples

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 Design

Study Type:
Observational
Actual Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
lung cancer patients

Diagnostic Test: collect samples
collect serum samples and clinical features

normol volunteers

Diagnostic Test: collect samples
collect serum samples and clinical features

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430022

Sponsors and Collaborators

  • Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yang Jin, professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier:
NCT03830619
Other Study ID Numbers:
  • WuhanUH2018
First Posted:
Feb 5, 2019
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yang Jin, professor, Wuhan Union Hospital, China
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2021