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

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ClinicalTrials.gov Identifier: NCT03324022

Recruitment Status : Recruiting

First Posted : October 27, 2017

Last Update Posted : October 31, 2017

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Sponsor:

Information provided by (Responsible Party):

National Taiwan University Hospital

Study Description

Brief 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.

Condition or disease
Graves Ophthalmopathy

Study Design

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Study Type :	Observational
Estimated Enrollment :	80 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease
Actual Study Start Date :	December 25, 2014
Estimated Primary Completion Date :	December 25, 2017
Estimated Study Completion Date :	December 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Thyroid Diseases

Drug Information available for: Thyroid Fibroblast growth factor

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Serum concentration of selected growth factors [ Time Frame: 1 year ]
Investigators would like to measure fibroblast growth factors concentration (ug/mL) by ELISA according to the manufacturers' instruction

Secondary Outcome Measures :

RNA expression level of selected growth factor receptors [ Time Frame: 1 year ]
Investigators would like to measure growth factor receptors expression level comparing to house-keeping gene using real-time PCR
RNA expression level of selected growth factor receptors [ Time Frame: 1 year ]
Investigators would like to measure adipogenesis-related genes expression level comparing to house-keeping gene using real-time PCR

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients with thyroid eye disease

Criteria

Inclusion Criteria:

diagnosed as thyroid eye disease
suggested to accept orbital decompression

Exclusion Criteria:

age below 20 or above 80
pregnancy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324022

Contacts

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Contact: Shyang-Rong Shih, M.D, Ph. D	+886-2-23123456 ext 65025	srshih@ntu.edu.tw

Locations

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Taiwan
National Taiwan University Hospital Taipei, Taiwan	Recruiting
Taipei, Taiwan
Contact: Shyang-Rong Shih, PhD 886-2-23123456 ext 61613 srshih@ntu.edu.tw
Principal Investigator: Shyang-Rong Shih, PhD

Sponsors and Collaborators

National Taiwan University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shih SR, Shih CW, Wei YH, Lu TX, Chou CH, Yen EY, Chang YC, Lin CC, Chi YC, Yang WS, Liao SL, Tsai FC. Fibroblast Growth Factor Receptor Inhibitors Reduce Adipogenesis of Orbital Fibroblasts and Enhance Myofibroblastic Differentiation in Graves' Orbitopathy. Ocul Immunol Inflamm. 2019 Oct 28:1-10. doi: 10.1080/09273948.2019.1672196. [Epub ahead of print]

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Responsible Party:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT03324022 History of Changes
Other Study ID Numbers:	201412026RINB
First Posted:	October 27, 2017 Key Record Dates
Last Update Posted:	October 31, 2017
Last Verified:	October 2017

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by National Taiwan University Hospital:


Fibroblast growth factors Fibroblast growth factors receptors Thyroid orbitopathy

Additional relevant MeSH terms:

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Graves Ophthalmopathy Eye Diseases Thyroid Diseases Endocrine System Diseases Eye Diseases, Hereditary Graves Disease Exophthalmos Orbital Diseases	Genetic Diseases, Inborn Goiter Hyperthyroidism Autoimmune Diseases Immune System Diseases Mitogens Mitosis Modulators Molecular Mechanisms of Pharmacological Action

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