Graves OphthalmopathyTEDNCT03324022
Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease
An observational study of Graves Ophthalmopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Graves Ophthalmopathy
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Dec 2014to 25 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with thyroid eye disease
Who may be able to join
- diagnosed as thyroid eye disease
- suggested to accept orbital decompression
Who cannot join
- age below 20 or above 80
- pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Taipei, Taiwan
Taipei
Shyang-Rong Shih, PhD, 886-2-23123456 ext. 61613, srshih@ntu.edu.tw
Shyang-Rong Shih, PhD
About this study
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.
- Conditions
- Graves Ophthalmopathy
- Keywords
- Fibroblast growth factors, Fibroblast growth factors receptors, Thyroid orbitopathy
- Medical subject headings
- Graves Ophthalmopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of selected growth factors
Investigators would like to measure fibroblast growth factors concentration (ug/mL) by ELISA according to the manufacturers' instruction
Measured: 1 year
Secondary outcomes (2)
RNA expression level of selected growth factor receptors
Investigators would like to measure growth factor receptors expression level comparing to house-keeping gene using real-time PCR
Measured: 1 year
RNA expression level of selected growth factor receptors
Investigators would like to measure adipogenesis-related genes expression level comparing to house-keeping gene using real-time PCR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start25 Dec 2014
- Primary completion25 Dec 2017 (estimated)
- Study completion25 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324022
- Sponsor's protocol ID
- 201412026RINB
- Acronym
- TED
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31657648
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT03324022
- Acronym / sponsor ID
- TED / 201412026RINB
- Conditions
- Graves Ophthalmopathy
- Keywords
- Fibroblast growth factors, Fibroblast growth factors receptors, Thyroid orbitopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Dec 2014 (actual)
- Primary completion
- 25 Dec 2017 (estimated)
- Study completion
- 25 Dec 2020 (estimated)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thyroid eye disease
Key inclusion criteria (2 listed)
- diagnosed as thyroid eye disease
- suggested to accept orbital decompression
Key exclusion criteria (2 listed)
- age below 20 or above 80
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
RNA expression level of selected growth factor receptors
Time frame: 1 year
RNA expression level of selected growth factor receptors
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 31657648Shih 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.
Related trials for Graves Ophthalmopathy
Not yet recruiting
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
Thyroid Autoimmune Disease, Hashimoto's Thyroiditis
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Graves' Disease, Graves Disease
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
Active, not recruitingPhase 4
Hydroxychloroquine in Mild Graves' Orbitopathy
Graves Ophthalmopathy
RecruitingPhase 2
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Ophthalmopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shyang-Rong Shih, M.D, Ph. D (+886-2-23123456 ext. 65025, srshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of selected growth factors (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03324022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.