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

NCT03830619 | Completed DMC

• 1 other identifier: WuhanUH2018
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer (Diagnosis)

Keywords

exosomes；lncRNA； lung cancer；

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

lung cancer patients

Diagnostic Test: collect samples

normol volunteers

Diagnostic Test: collect samples

Interventions

collect samples DIAGNOSTIC_TEST

collect serum samples and clinical features

lung cancer patients; normol volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 5, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2021
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)