ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02325596
Recruitment Status : Unknown
Verified December 2014 by Guo-hua Hu, First Affiliated Hospital of Chongqing Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : December 25, 2014
Last Update Posted : December 25, 2014
Sponsor:
Information provided by (Responsible Party):
Guo-hua Hu, First Affiliated Hospital of Chongqing Medical University

Brief Summary:
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 or disease Intervention/treatment
Rhinosinusitis Genetic: miRNA mimics or inhibitors

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
Estimated Enrollment : 70 participants
Observational Model: Case Control
Official Title: Investigate the Role of microRNA in Chronic Rhinosinusitis From DC-Th Axis
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2016

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




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

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): 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

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
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014

Keywords provided by Guo-hua Hu, 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