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

October 29, 2017 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shyang-Rong Shih, M.D, Ph. D
  • Phone Number: 65025 +886-2-23123456
  • Email: srshih@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital Taipei, Taiwan
        • Principal Investigator:
          • Shyang-Rong Shih, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with thyroid eye disease

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • age below 20 or above 80
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2014

Primary Completion (Anticipated)

December 25, 2017

Study Completion (Anticipated)

December 25, 2020

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 29, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201412026RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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