NCT03151954

Brief 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.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

3.3 years

First QC Date

April 21, 2017

Last Update Submit

September 10, 2018

Conditions

Nasal Polyps

Keywords

nasal epithelium stem cellsHippo-YAP pathwayproliferationdifferentiation

Outcome Measures

Primary Outcomes (2)

  • location of YAP in tissues

    through Immunohistochemistry

    through study completion, an average of 2 years

  • protein expression level of YAP in tissues

    through western blot

    through study completion, an average of 2 years

Secondary Outcomes (5)

  • expression level of Th1 cytokines in the tissues

    through study completion, an average of 2 years

  • expression level of Th17 cytokines in the tissues

    through study completion, an average of 2 years

  • activation of hippo-YAP in NSECs on protein aspect

    through study completion, an average of 2 years

  • activation of hippo-YAP in NSECs

    through study completion, an average of 2 years

  • activation of hippo-YAP in NSECs on gene aspect

    through study completion, an average of 2 years

Study Arms (2)

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.

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.

Procedure: nasal septal construction

Interventions

functional endonasal sinus surgeryPROCEDURE

collect nasal polyps from patients

Also known as: FESS
nasal polyps
nasal septal constructionPROCEDURE

collect inferior turbinates from patients as control arm

inferior turbinate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The Poor Health
  • Be allergic to anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ThirdSunYatSen

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

huiyi DENG, MD

CONTACT

15521127735deng.huiyi@foxmail.com

qintai YANG, PhD

CONTACT

13724859848yang.qt@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate, Head of Otolaryngology, Principal Investigator

Study Record Dates

First Submitted

April 21, 2017

First Posted

May 12, 2017

Study Start

April 20, 2017

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

CN(1)