Graves' DiseaseNCT01182584
Application of Digital Infrared Thermal Imaging (DITI) in Graves' Disease
An observational study of Graves' Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy. Pathogenesis involves autoimmune process. The investigators think temperatures of the area involved in the inflammation may change. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Graves' Disease
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Dec 2011
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Graves' disease patients with or without ophthalmopathy and dermopathy
Who may be able to join
- Graves' disease patients. Healthy people
Who cannot join
- Pregnancy. <16 years old or > 60 years old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei
Shyang-Rong Shih, M.D., 0972653337, srshih@ntu.edu.tw
About this study
Official title: Application of Digital Infrared Thermal Imaging in Thyroid Disease and Associated Ophthalmopathy and Dermopathy
Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy. Pathogenesis involves autoimmune process. The investigators think temperatures of the area involved in the inflammation may change. Thus the investigators plan to take temperature pictures of Graves' patients using digital infrared thermal imaging system and observe the change.
Read the detailed description
We will recruited patients of Graves' disease from out patient clinics. We will perform thyroid echo and soft tissue echo first. Then we let patients sit before the thermal camera and take thermal images of eyes necks and tibia. After data collection, we analyse the relation between temperature and laboratory data such as thyroid function and autoimmune profiles.
- Conditions
- Graves' Disease
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Graves' disease | Not described | |
| Healthy volunteers | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startDec 2009
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shyang-Rong Shih, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182584
- Sponsor's protocol ID
- 200811040R
- Status last verified
- Dec 2010
- First submitted
- 12 Aug 2010
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Digital Infrared Thermal Imaging in Thyroid Disease and Associated Ophthalmopathy and Dermopathy
- ClinicalTrials.gov ID
- NCT01182584
- Acronym / sponsor ID
- 200811040R
- Conditions
- Graves' Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 17 Aug 2010 (estimated)
- 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' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy. Pathogenesis involves autoimmune process. The investigators think temperatures of the area involved in the inflammation may change. Thus the investigators plan to take temperature pictures of Graves' patients using digital infrared thermal imaging system and observe the change.
Detailed description
We will recruited patients of Graves' disease from out patient clinics. We will perform thyroid echo and soft tissue echo first. Then we let patients sit before the thermal camera and take thermal images of eyes necks and tibia. After data collection, we analyse the relation between temperature and laboratory data such as thyroid function and autoimmune profiles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graves' disease | – | – |
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Graves' disease patients with or without ophthalmopathy and dermopathy
Key inclusion criteria (1 listed)
- Graves' disease patients. Healthy people
Key exclusion criteria (1 listed)
- Pregnancy. <16 years old or > 60 years old
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2010.
Related trials for Graves' Disease
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.
Shyang-Rong Shih principal investigator
National Taiwan University
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' Disease, 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 1 inclusion and 1 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 22 Dec 2010. 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. (0972653337, srshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 22 Dec 2010.