NCT02325596

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 25, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

December 15, 2014

Last Update Submit

December 24, 2014

Conditions

Keywords

Chronic rhinosinusitismicroRNAdendritic cellhelper T cell

Outcome Measures

Primary Outcomes (1)

  • Abnormal microRNA in the Chronic Rhinosinusitis are found by gene chip and qPCR.

    6 to 24 months post procedure

Study Arms (4)

control

Patients with only nasal septum deviation

Genetic: miRNA mimics or inhibitors

CRS sNP

Chronic Rhinosinusitis patients without nasal polyps

Genetic: miRNA mimics or inhibitors

atopic CRS wNP

Chronic Rhinosinusitis patients with allergic constitution and nasal polyps

Genetic: miRNA mimics or inhibitors

non-atopic CRS wNP

Chronic Rhinosinusitis patients with nasal polyps but not allergic constitution

Genetic: miRNA mimics or inhibitors

Interventions

DCs are transfected by the miRNA mimics or inhibitors after they are separated from peripheral blood mononuclear cells in CRS patients

CRS sNPatopic CRS wNPcontrolnon-atopic CRS wNP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Guo-hua Hu HG Guo-hua Hu, MD

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigate the Role of microRNA in Chronic Rhinosinusitis From DC-Th Axis

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 25, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

December 1, 2016

Last Updated

December 25, 2014

Record last verified: 2014-12

Locations