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

November 15, 2021 updated by: Yang Jin, Wuhan Union Hospital, China
The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as a biomarker for the diagnosis of lung cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed as lung cancer by histopathology or cytopathology in union hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The expression levels of serum exosome long non-coding RNA
Time Frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
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
Time Frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
the CT scans of the lung for the patients
Time Frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

July 31, 2021

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

February 2, 2019

First Posted (ACTUAL)

February 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WuhanUH2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share IPD now

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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