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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

Tracking Information
First Submitted Date October 16, 2017
First Posted Date October 27, 2017
Last Update Posted Date October 31, 2017
Actual Study Start Date December 25, 2014
Estimated Primary Completion Date December 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2017)
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
Original Primary Outcome Measures
 (submitted: October 24, 2017)
Serum concentration of selected growth factors [ Time Frame: 1 year ]
We would like to measure fibroblast growth factors concentration (ug/mL) by ELISA according to the manufacturers' instruction
Change History Complete list of historical versions of study NCT03324022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 29, 2017)
  • 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
Original Secondary Outcome Measures
 (submitted: October 24, 2017)
  • RNA expression level of selected growth factor receptors [ Time Frame: 1 year ]
    We 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 ]
    We would like to measure adipopgenesis-related genes expression level comparing to house-keeping gene using real-time PCR
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease
Official Title Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with thyroid eye disease
Condition Graves Ophthalmopathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 24, 2017)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 25, 2020
Estimated Primary Completion Date December 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosed as thyroid eye disease
  • suggested to accept orbital decompression

Exclusion Criteria:

  • age below 20 or above 80
  • pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Shyang-Rong Shih, M.D, Ph. D +886-2-23123456 ext 65025 srshih@ntu.edu.tw
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03324022
Other Study ID Numbers 201412026RINB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account National Taiwan University Hospital
Verification Date October 2017