Clincosm LogoSign in Get a demo

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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03324022
Collaborator
(none)
80
Enrollment
1
Location
72
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Dec 25, 2014
    Anticipated Primary Completion Date :
    Dec 25, 2017
    Anticipated Study Completion Date :
    Dec 25, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Serum concentration of selected growth factors [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 [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 [1 year]

      Investigators would like to measure adipogenesis-related genes expression level comparing to house-keeping gene using real-time PCR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • diagnosed as thyroid eye disease

    • suggested to accept orbital decompression

    Exclusion Criteria:

    • age below 20 or above 80

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei, Taiwan Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03324022
    Other Study ID Numbers:
    • 201412026RINB
    First Posted:
    Oct 27, 2017
    Last Update Posted:
    Oct 31, 2017
    Last Verified:
    Oct 1, 2017
    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:
    Eye Diseases
    Graves Ophthalmopathy

    Study Results

    No Results Posted as of Oct 31, 2017