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Trial record 44 of 127 for:    exosomes

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

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ClinicalTrials.gov Identifier: NCT03830619
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Yang Jin, Wuhan Union Hospital, China

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
Lung Cancer (Diagnosis) 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients diagnosed as lung cancer by histopathology or cytopathology in union hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830619


Contacts
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Contact: Yang Jin, preofessor 13554361146 ext 027-85755457 whuhjy@126.com

Locations
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China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Yang Jin, professor    13554361146 ext 027-85755457    whuhjy@126.com   
Sponsors and Collaborators
Wuhan Union Hospital, China

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Responsible Party: Yang Jin, professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT03830619     History of Changes
Other Study ID Numbers: WuhanUH2018
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share IPD now

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yang Jin, Wuhan Union Hospital, China:
exosomes;lncRNA; lung cancer;
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases