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Completed

NCT Number: NCT03830619

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

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

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Key information

Conditions

Lung Cancer (Diagnosis) Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collect samples

Diagnostic Test

collect serum samples and clinical features

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Feb 5, 2019
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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