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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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

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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





Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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



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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

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

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