Nasal PolypsNCT03151954
The Activation of Hippo Pathway in Nasal Polyps
A study testing functional endonasal sinus surgery and nasal septal construction in people with Nasal Polyps, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Hippo-YAP pathway is a newly discovered pathway controlling the growth, and plays important roles in the regulation of stem cell function and tissue regeneration. Previously we found that a higher expression of YAP in NP, and LPS was able to activate the hippo-YAP pathway in NESCs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- functional endonasal sinus surgery and nasal septal construction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2017to 31 Jul 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of nasal polyps or deviation of nasal septum based on CT
- Must be able to withstand surgery
- At least 18 years old
- A sufficient level of education to understand study procedures and be able to communicate with site personnel and adhere to the follow-up;
- Accepted informed consent verbally and in writing
Who cannot join
- The Poor Health
- Be allergic to anesthetics
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ThirdSunYatSen
Guangzhou, Guangdong, 510630
Huiyi DENG, MD, 15521127735, deng.huiyi@foxmail.com
Qintai YANG, Ph.D, 13724859848, yang.qt@126.com
About this study
Official title: Yap, the Nuclear Target of Hippo Signaling, Regulates Nasal Epithelium Stem Cells Aberrant Proliferation and Differentiation in Nasal Polyps
Hippo-YAP pathway is a newly discovered pathway controlling the growth, and plays important roles in the regulation of stem cell function and tissue regeneration. Previously we found that a higher expression of YAP in NP, and LPS was able to activate the hippo-YAP pathway in NESCs. Thus, we hypothesize that the aberrant proliferation and differentiation of NESCs could be regulated via the hippo-YAP pathway.
Read the detailed description
Studies have shown that the development of nasal polyps (NP) are closely related to the epithelial remodeling.The investigators have shown that nasal epithelial stem cells(NESCs) derived from NP had reduced growth and proliferation dynamics in vitro culture,and differentiated into ciliated cells with impaired cilia architecture and ciliogenesis.Further studies demonstrated that NESCs were involved in the aberrant damage repair process of the epithelial remodeling in NP.Hippo-YAP pathway is a newly discovered pathway controlling the growth,and plays important roles in the regulation of stem cell function and tissue regeneration.Previously the investigators found that a higher expression of YAP in NP,and LPS was able to activate the hippo-YAP pathway in NESCs.Thus,the investigators hypothesize that the aberrant proliferation and differentiation of NESCs could be regulated via the hippo-YAP pathway,which may result in the epithelial remodeling.In this study,the investigators intend to investigate the mechanism of the hippo-YAP pathway in regulating aberrant proliferation and differentiation of NESCs and explore its upstream signaling and downstream target genes,using the NESCs gas-liquid interface culture system,and a silencing and overexpression of the hippo-YAP pathway component strategy.The investigators aim to unravel the effect and mechanism of the hippo-YAP pathway in the epithelial remodeling of NP,providing new targets and strategy for the improvement or reversal of NP epithelial remodeling.
- Conditions
- Nasal Polyps
- Being tested
- functional endonasal sinus surgery, nasal septal construction
- Keywords
- nasal epithelium stem cells, Hippo-YAP pathway, proliferation, differentiation
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional endonasal sinus surgeryProcedure or surgery
Also called FESS
collect nasal polyps from patients
nasal septal constructionProcedure or surgery
collect inferior turbinates from patients as control arm
| Study group | Role | What they receive |
|---|---|---|
| nasal polyps | Experimental | 1. Explore the degree of abnormal proliferation in NESCs,and analyze the relationship between the proliferation and the activation of hippo-YAP pathway,then explore the levels of LPS and Th2/17 cytokines in nasal polyps,and the relation between cytokines and the activation of hippo-YAP pathway through Immunohistochemistry and Immunofluorescence （P63、Ki67、YAP、LATS1/2 and MST1/2），as well as Western Blot and the Flow cytometry.
2. Explore if the LPS and LPS and Th2/17 cytokines, as well as the epidermal growth factors can effect the hippo-YAP pathway of NESCs through cell culture, Western Blot and Real time PCR,and test the YAP expression and location through Immunohistochemistry.
3. Explore that how the hippo-YAP effect the proliferation and differentiation of NESCs through cell transfection;
4. Explore the regulation of hippo-YAP pathway in NESCs. Receives: Procedure: functional endonasal sinus surgery |
| inferior turbinate | Placebo comparator | Compared with nasal polyps,explore the levels of LPS and Th2/17 cytokines in nasal polyps,and the relation between cytokines and the activation of hippo-YAP pathway through Immunohistochemistry and Immunofluorescence（P63、Ki67、YAP、LATS1/2 and MST1/2），as well as Western Blot and the Flow cytometry. Receives: Procedure: nasal septal construction |
What is being measured
The primary outcome is the main question the study is designed to answer.
location of YAP in tissues
through Immunohistochemistry
Measured: through study completion, an average of 2 years
protein expression level of YAP in tissues
through western blot
Measured: through study completion, an average of 2 years
Secondary outcomes (5)
expression level of Th1 cytokines in the tissues
through Flow cytometry
Measured: through study completion, an average of 2 years
expression level of Th17 cytokines in the tissues
through Flow cytometry
Measured: through study completion, an average of 2 years
activation of hippo-YAP in NSECs on protein aspect
Western Blot
Measured: through study completion, an average of 2 years
activation of hippo-YAP in NSECs
Flow cytometry
Measured: through study completion, an average of 2 years
activation of hippo-YAP in NSECs on gene aspect
quantitive real time PCR
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start20 Apr 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Deng Huiyi, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151954
- Sponsor's protocol ID
- NSFC-H1301
- Status last verified
- Sep 2018
- First submitted
- 21 Apr 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yap, the Nuclear Target of Hippo Signaling, Regulates Nasal Epithelium Stem Cells Aberrant Proliferation and Differentiation in Nasal Polyps
- ClinicalTrials.gov ID
- NCT03151954
- Acronym / sponsor ID
- NSFC-H1301
- Conditions
- Nasal Polyps
- Keywords
- nasal epithelium stem cells, Hippo-YAP pathway, proliferation, differentiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 12 May 2017 (actual)
- 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.
Hippo-YAP pathway is a newly discovered pathway controlling the growth, and plays important roles in the regulation of stem cell function and tissue regeneration. Previously we found that a higher expression of YAP in NP, and LPS was able to activate the hippo-YAP pathway in NESCs. Thus, we hypothesize that the aberrant proliferation and differentiation of NESCs could be regulated via the hippo-YAP pathway.
Detailed description
Studies have shown that the development of nasal polyps (NP) are closely related to the epithelial remodeling.The investigators have shown that nasal epithelial stem cells(NESCs) derived from NP had reduced growth and proliferation dynamics in vitro culture,and differentiated into ciliated cells with impaired cilia architecture and ciliogenesis.Further studies demonstrated that NESCs were involved in the aberrant damage repair process of the epithelial remodeling in NP.Hippo-YAP pathway is a newly discovered pathway controlling the growth,and plays important roles in the regulation of stem cell function and tissue regeneration.Previously the investigators found that a higher expression of YAP in NP,and LPS was able to activate the hippo-YAP pathway in NESCs.Thus,the investigators hypothesize that the aberrant proliferation and differentiation of NESCs could be regulated via the hippo-YAP pathway,which may result in the epithelial remodeling.In this study,the investigators intend to investigate the mechanism of the hippo-YAP pathway in regulating aberrant proliferation and differentiation of NESCs and explore its upstream signaling and downstream target genes,using the NESCs gas-liquid interface culture system,and a silencing and overexpression of the hippo-YAP pathway component strategy.The investigators aim to unravel the effect and mechanism of the hippo-YAP pathway in the epithelial remodeling of NP,providing new targets and strategy for the improvement or reversal of NP epithelial remodeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal polyps | Experimental | Procedure: functional endonasal sinus surgery1. Explore the degree of abnormal proliferation in NESCs,and analyze the relationship between the proliferation and the activation of hippo-YAP pathway,then explore the levels of LPS and Th2/17 cytokines in nasal polyps,and the relation between cytokines and the activation of hippo-YAP pathway through Immunohistochemistry and Immunofluorescence （P63、Ki67、YAP、LATS1/2 and MST1/2），as well as Western Blot and the Flow cytometry. 2. Explore if the LPS and LPS and Th2/17 cytokines, as well as the epidermal growth factors can effect the hippo-YAP pathway of NESCs through cell culture, Western Blot and Real time PCR,and test the YAP expression and location through Immunohistochemistry. 3. Explore that how the hippo-YAP effect the proliferation and differentiation of NESCs through cell transfection; 4. Explore the regulation of hippo-YAP pathway in NESCs. |
| inferior turbinate | Placebo comparator | Procedure: nasal septal constructionCompared with nasal polyps,explore the levels of LPS and Th2/17 cytokines in nasal polyps,and the relation between cytokines and the activation of hippo-YAP pathway through Immunohistochemistry and Immunofluorescence（P63、Ki67、YAP、LATS1/2 and MST1/2），as well as Western Blot and the Flow cytometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of nasal polyps or deviation of nasal septum based on CT
- Must be able to withstand surgery
- At least 18 years old
- A sufficient level of education to understand study procedures and be able to communicate with site personnel and adhere to the follow-up;
- Accepted informed consent verbally and in writing
Key exclusion criteria (2 listed)
- The Poor Health
- Be allergic to anesthetics
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 |
|---|---|---|
| functional endonasal sinus surgeryAlso: FESScollect nasal polyps from patients | Procedure or surgery | nasal polyps |
| nasal septal constructioncollect inferior turbinates from patients as control arm | Procedure or surgery | inferior turbinate |
Primary outcome
location of YAP in tissues
Time frame: through study completion, an average of 2 years
through Immunohistochemistry
protein expression level of YAP in tissues
Time frame: through study completion, an average of 2 years
through western blot
5 secondary outcomes
expression level of Th1 cytokines in the tissues
Time frame: through study completion, an average of 2 years
expression level of Th17 cytokines in the tissues
Time frame: through study completion, an average of 2 years
activation of hippo-YAP in NSECs on protein aspect
Time frame: through study completion, an average of 2 years
activation of hippo-YAP in NSECs
Time frame: through study completion, an average of 2 years
activation of hippo-YAP in NSECs on gene aspect
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional endonasal sinus surgery and nasal septal construction in people with Nasal Polyps, run by Third Affiliated Hospital, Sun Yat-Sen 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 11 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Contact huiyi DENG, MD (15521127735, deng.huiyi@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
location of YAP in tissues (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2018.