Investigate the Role of microRNA in Chronic Rhinosinusitis From DC-Th Axis (ITROMICRFDTA)

December 24, 2014 updated by: Guo-hua Hu, First Affiliated Hospital of Chongqing Medical University
This study aimed to evaluate the upstream events of Th17/Treg imbalance in CRS and their immune regulatory factors. Then the investigators aimed to explore the regulatory role of miRNA on DC-Th axis and its dysfunction in the pathogenesis of CRS, in order to determine the miRNA expression profile in CRS and clarify the role of miRNA in the pathogenesis of CRS by regulating the DC-Th axis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic rhinosinusitis (CRS), commonly encountered in the field of clinical otorhinolaryngology, is still a challenging proposition for doctors because of its high incidence and the unsatisfactory treatment outcomes. Nowadays, studies on the pathogenesis of NP are still attached great importance by researchers from each country. NP has become a global health problem with a considerable socioeconomic burden. Recently, research showed that the impaired balance of Th17/Treg was the significant basis of NP. Nevertheless, the pathogenesis of Th17/Treg imbalance was unclear. In this study, DC-Th axis was designed as the main line, and the regulation of miRNA on DC was designed as the entry point. This study aimed to evaluate the upstream events of Th17/Treg imbalance in CRS and their immune regulatory factors. Then the investigators aimed to explore the regulatory role of miRNA on DC-Th axis and its dysfunction in the pathogenesis of CRS, in order to determine the miRNA expression profile in CRS and clarify the role of miRNA in the pathogenesis of CRS by regulating the DC-Th axis. This study will play an important role in clarifying the pathogenesis of CRS eventually and will fill the blanks of the research between miRNA and CRS in the investigators'country. This study is with important clinical value for establishing control strategies for CRS.

Study Type

Observational

Enrollment (Anticipated)

70

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
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be selected from the department of endoscopic sinus surgery in the First Affiliated Hospital of Chongqing Medical University.

Description

Inclusion Criteria:

  1. CRS diagnosis is accord with diagnostic criteria of The European nasal sinusitis, nasal polyps guidelines (EPOS 2012) .
  2. Selected subjects are stopped using systemic or topical corticosteroids in one month before experiment.
  3. All the patients have sinus CT and nasal endoscopy and allergen Skin Prick Test in preoperative.
  4. Aged from 18 to 75 years old.
  5. Woman or man.

Exclusion Criteria:

  1. Choanal polyp, fungal nasal sinusitis, cystic fibrosis.
  2. Acute upper respiratory tract infection and other diseases associated with the body.

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
control
Patients with only nasal septum deviation
Genetic: miRNA mimics or inhibitors
DCs are transfected by the miRNA mimics or inhibitors after they are separated from peripheral blood mononuclear cells in CRS patients
CRS sNP
Chronic Rhinosinusitis patients without nasal polyps
Genetic: miRNA mimics or inhibitors
DCs are transfected by the miRNA mimics or inhibitors after they are separated from peripheral blood mononuclear cells in CRS patients
atopic CRS wNP
Chronic Rhinosinusitis patients with allergic constitution and nasal polyps
Genetic: miRNA mimics or inhibitors
DCs are transfected by the miRNA mimics or inhibitors after they are separated from peripheral blood mononuclear cells in CRS patients
non-atopic CRS wNP
Chronic Rhinosinusitis patients with nasal polyps but not allergic constitution
Genetic: miRNA mimics or inhibitors
DCs are transfected by the miRNA mimics or inhibitors after they are separated from peripheral blood mononuclear cells in CRS patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abnormal microRNA in the Chronic Rhinosinusitis are found by gene chip and qPCR.
Time Frame: 6 to 24 months post procedure
6 to 24 months post procedure

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Chongqing Medical University

Investigators

  • Principal Investigator: Guo-hua Hu HG Guo-hua Hu, MD, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

December 24, 2014

First Posted (Estimate)

December 25, 2014

Study Record Updates

Last Update Posted (Estimate)

December 25, 2014

Last Update Submitted That Met QC Criteria

December 24, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSFC-81271061

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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