NCT03324022

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

October 16, 2017

Last Update Submit

October 29, 2017

Conditions

Keywords

Fibroblast growth factorsFibroblast growth factors receptorsThyroid orbitopathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • RNA expression level of selected growth factor receptors

    1 year

  • RNA expression level of selected growth factor receptors

    1 year

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with thyroid eye disease

You may qualify if:

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

You may not qualify if:

  • age below 20 or above 80
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Taipei, Taiwan

Taipei, Taiwan

RECRUITING

Related Publications (1)

  • Shih SR, Liao SL, Shih CW, Wei YH, Lu TX, Chou CH, Yen EY, Chang YC, Lin CC, Chi YC, Yang WS, Tsai FC. Fibroblast Growth Factor Receptor Inhibitors Reduce Adipogenesis of Orbital Fibroblasts and Enhance Myofibroblastic Differentiation in Graves' Orbitopathy. Ocul Immunol Inflamm. 2021 Jan 2;29(1):193-202. doi: 10.1080/09273948.2019.1672196. Epub 2019 Oct 28.

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Shyang-Rong Shih, M.D, Ph. D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 27, 2017

Study Start

December 25, 2014

Primary Completion

December 25, 2017

Study Completion

December 25, 2020

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations