The Activation of Hippo Pathway in Nasal Polyps

Nasal Polyps Clinical Trial

Official title:

Yap, the Nuclear Target of Hippo Signaling, Regulates Nasal Epithelium Stem Cells Aberrant Proliferation and Differentiation in Nasal Polyps

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03151954
• Other study ID #: NSFC-H1301
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2018
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: huiyi DENG, MD
• Phone: 15521127735
• Email: deng.huiyi[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Thus, we hypothesize that the aberrant proliferation and differentiation of NESCs could be regulated via the hippo-YAP pathway.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• The Poor Health

• Be allergic to anesthetics

Related Conditions & MeSH terms

• Nasal Polyps
• Polyps

Intervention

Procedure:
• functional endonasal sinus surgery
collect nasal polyps from patients
• nasal septal construction
collect inferior turbinates from patients as control arm

Locations

Country	Name	City	State
China	ThirdSunYatSen	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University	National University, Singapore

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	location of YAP in tissues	through Immunohistochemistry	through study completion, an average of 2 years
Primary	protein expression level of YAP in tissues	through western blot	through study completion, an average of 2 years
Secondary	expression level of Th1 cytokines in the tissues	through Flow cytometry	through study completion, an average of 2 years
Secondary	expression level of Th17 cytokines in the tissues	through Flow cytometry	through study completion, an average of 2 years
Secondary	activation of hippo-YAP in NSECs on protein aspect	Western Blot	through study completion, an average of 2 years
Secondary	activation of hippo-YAP in NSECs	Flow cytometry	through study completion, an average of 2 years
Secondary	activation of hippo-YAP in NSECs on gene aspect	quantitive real time PCR	through study completion, an average of 2 years