Clinical trial NCT02325596: Investigate the Role of microRNA in Chronic Rhinosinusitis From DC-Th Axis
Official title: Investigate the Role of microRNA in Chronic Rhinosinusitis From DC-Th Axis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rhinosinusitis
Keywords: Chronic rhinosinusitis
microRNA
dendritic cell
helper T cell
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
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.

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.

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 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.

Primary outcomes:
measure: Abnormal microRNA in the Chronic Rhinosinusitis are found by gene chip and qPCR.
timeFrame: 6 to 24 months post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Guo-hua Hu HG Guo-hua Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma ZX, Tan X, Shen Y, Ke X, Yang YC, He XB, Wang ZH, Dai YB, Hong SL, Hu GH. MicroRNA expression profile of mature dendritic cell in chronic rhinosinusitis. Inflamm Res. 2015 Nov;64(11):885-93. doi: 10.1007/s00011-015-0870-5. Epub 2015 Sep 4.