RhinosinusitisITROMICRFDTANCT02325596
Investigate the Role of microRNA in Chronic Rhinosinusitis From DC-Th Axis
An observational study of Rhinosinusitis, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- miRNA mimics or inhibitors
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from the department of endoscopic sinus surgery in the First Affiliated Hospital of Chongqing Medical University.
Who may be able to join
- 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.
Who cannot join
- Choanal polyp, fungal nasal sinusitis, cystic fibrosis.
- Acute upper respiratory tract infection and other diseases associated with the body.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
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.
Read the 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.
- Conditions
- Rhinosinusitis
- Being tested
- miRNA mimics or inhibitors
- Keywords
- Chronic rhinosinusitis, microRNA, dendritic cell, helper T cell
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNA mimics or inhibitorsGenetic
DCs are transfected by the miRNA mimics or inhibitors after they are separated from peripheral blood mononuclear cells in CRS patients
| Study group | Role | What they receive |
|---|---|---|
| control | Patients with only nasal septum deviation Receives: Genetic: miRNA mimics or inhibitors | |
| CRS sNP | Chronic Rhinosinusitis patients without nasal polyps Receives: Genetic: miRNA mimics or inhibitors | |
| atopic CRS wNP | Chronic Rhinosinusitis patients with allergic constitution and nasal polyps Receives: Genetic: miRNA mimics or inhibitors | |
| non-atopic CRS wNP | Chronic Rhinosinusitis patients with nasal polyps but not allergic constitution Receives: Genetic: miRNA mimics or inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal microRNA in the Chronic Rhinosinusitis are found by gene chip and qPCR.
Measured: 6 to 24 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-hua Hu, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Guo-hua Hu HG Guo-hua Hu, MD, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325596
- Sponsor's protocol ID
- NSFC-81271061
- Acronym
- ITROMICRFDTA
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26337346
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Role of microRNA in Chronic Rhinosinusitis From DC-Th Axis
- ClinicalTrials.gov ID
- NCT02325596
- Acronym / sponsor ID
- ITROMICRFDTA / NSFC-81271061
- Conditions
- Rhinosinusitis
- Keywords
- Chronic rhinosinusitis, microRNA, dendritic cell, helper T cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | – | Genetic: miRNA mimics or inhibitorsPatients with only nasal septum deviation |
| CRS sNP | – | Genetic: miRNA mimics or inhibitorsChronic Rhinosinusitis patients without nasal polyps |
| atopic CRS wNP | – | Genetic: miRNA mimics or inhibitorsChronic Rhinosinusitis patients with allergic constitution and nasal polyps |
| non-atopic CRS wNP | – | Genetic: miRNA mimics or inhibitorsChronic Rhinosinusitis patients with nasal polyps but not allergic constitution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the department of endoscopic sinus surgery in the First Affiliated Hospital of Chongqing Medical University.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Choanal polyp, fungal nasal sinusitis, cystic fibrosis.
- Acute upper respiratory tract infection and other diseases associated with the body.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miRNA mimics or inhibitorsDCs are transfected by the miRNA mimics or inhibitors after they are separated from peripheral blood mononuclear cells in CRS patients | Genetic | CRS sNP, atopic CRS wNP, control, non-atopic CRS wNP |
Primary outcome
Abnormal microRNA in the Chronic Rhinosinusitis are found by gene chip and qPCR.
Time frame: 6 to 24 months post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2014.
- Derived from this study: PubMed 26337346Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo-hua Hu HG Guo-hua Hu, MD principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinosinusitis, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal microRNA in the Chronic Rhinosinusitis are found by gene chip and qPCR. (time frame: 6 to 24 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2014.