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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by First Affiliated Hospital of Chongqing Medical University.
Recruitment status was:  Enrolling by invitation
Sponsor:
Information provided by (Responsible Party):
Guo-hua Hu, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT02325596
First received: December 15, 2014
Last updated: December 24, 2014
Last verified: December 2014
  Purpose
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.

Condition Intervention
Rhinosinusitis
Genetic: miRNA mimics or inhibitors

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Investigate the Role of microRNA in Chronic Rhinosinusitis From DC-Th Axis

Further study details as provided by First Affiliated Hospital of Chongqing Medical University:

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

Estimated Enrollment: 70
Study Start Date: July 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02325596

Locations
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guo-hua Hu, Investigate the Role of microRNA in Chronic Rhinosinusitis From DC-Th Axis, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02325596     History of Changes
Other Study ID Numbers: NSFC-81271061
Study First Received: December 15, 2014
Last Updated: December 24, 2014

Keywords provided by First Affiliated Hospital of Chongqing Medical University:
Chronic rhinosinusitis
microRNA
dendritic cell
helper T cell

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 25, 2017