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

Rhinosinusitis Clinical Trial

— ITROMICRFDTA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02325596
• Other study ID #: NSFC-81271061
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 15, 2014
• Last updated: December 24, 2014
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Rhinosinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal microRNA in the Chronic Rhinosinusitis are found by gene chip and qPCR.		6 to 24 months post procedure	Yes