Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease

Graves Ophthalmopathy Clinical Trial

— TED  

Official title:

Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03324022
• Other study ID #: 201412026RINB
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2017
• Last updated: October 29, 2017
• Start date: December 25, 2014
• Est. completion date: December 25, 2020

Study information

• Verified date: October 2017
• Source: National Taiwan University Hospital
• Contact: Shyang-Rong Shih, M.D, Ph. D
• Phone: +886-2-23123456
• Email: srshih[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Graves' orbitopathy (GO) affects about 50% of patients with Graves' disease (GD), and some cannot be cured by current treatments. Orbital fibroblasts involves in the pathogenesis of GO by producing glycosaminoglycans and inflammatory cytokines. Since fibroblast growth factors (FGFs) binding to FGF receptors (FGFRs) can induce proliferation and differentiation of fibroblasts, investigators would like to measure the expression of FGFs and FGFRs in GO patients to see if inhibition of FGF-FGFR pathway has potential in treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 25, 2020
• Est. primary completion date: December 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosed as thyroid eye disease

• suggested to accept orbital decompression

Exclusion Criteria:

• age below 20 or above 80

• pregnancy

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Taipei, Taiwan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentration of selected growth factors	Investigators would like to measure fibroblast growth factors concentration (ug/mL) by ELISA according to the manufacturers' instruction	1 year
Secondary	RNA expression level of selected growth factor receptors	Investigators would like to measure growth factor receptors expression level comparing to house-keeping gene using real-time PCR	1 year
Secondary	RNA expression level of selected growth factor receptors	Investigators would like to measure adipogenesis-related genes expression level comparing to house-keeping gene using real-time PCR	1 year