Graves DiseaseNCT02210741
Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease
An observational study of Graves Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic predisposition. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Graves Disease
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient from our hospital, National Taiwan University Hospital
Patients with Graves disease
Trial locations and contacts
1 site in 1 country.
About this study
Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic predisposition. Despite its clinical and scientific significance, Graves' disease is still mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The immune repertoire, being the sum of T and B lymphocytes in a body at any given time, is both a snapshot and a historical record of a person's immune function. Thanks to the power of next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell receptors suddenly becomes plausible, and opens a door for many creative approaches to study immune related diseases. The ultimate goal of this project is to use both the NGS deep sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic fine mapping, and to identify Graves' disease-specific T cell and B cell receptors. Furthermore, using the immune repertoire approach, investigators want to study the critical epitopes of thyroid auto-antigens, and to delineate the pathophysiological steps in various disease stages and in various sub-groups. Investigators expect to solve the immune repertoire of Graves' disease of different sub-group presentations and at various disease activity stages.
- Conditions
- Graves Disease
- Keywords
- immune repertoire, Graves' disease
- Medical subject headings
- Graves Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
B lymphocyte and T lymphocyte receptor profiles of Graves' disease patients
"B lymphocyte and T lymphocyte receptor profiles" mean the sequence of the receptors and also the quantity of the lymphocytes with those specific receptor sequences.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tien-Chun Chang, Principal investigator, Professor of Department of Internal Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210741
- Sponsor's protocol ID
- 201312091RINB
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease
- ClinicalTrials.gov ID
- NCT02210741
- Acronym / sponsor ID
- 201312091RINB
- Conditions
- Graves Disease
- Keywords
- immune repertoire, Graves' disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 7 Aug 2014 (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 (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic predisposition. Despite its clinical and scientific significance, Graves' disease is still mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The immune repertoire, being the sum of T and B lymphocytes in a body at any given time, is both a snapshot and a historical record of a person's immune function. Thanks to the power of next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell receptors suddenly becomes plausible, and opens a door for many creative approaches to study immune related diseases. The ultimate goal of this project is to use both the NGS deep sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic fine mapping, and to identify Graves' disease-specific T cell and B cell receptors. Furthermore, using the immune repertoire approach, investigators want to study the critical epitopes of thyroid auto-antigens, and to delineate the pathophysiological steps in various disease stages and in various sub-groups. Investigators expect to solve the immune repertoire of Graves' disease of different sub-group presentations and at various disease activity stages.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient from our hospital, National Taiwan University Hospital
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
B lymphocyte and T lymphocyte receptor profiles of Graves' disease patients
Time frame: Three years
"B lymphocyte and T lymphocyte receptor profiles" mean the sequence of the receptors and also the quantity of the lymphocytes with those specific receptor sequences.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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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.
Tien-Chun Chang principal investigator
Professor of Department of Internal Medicine, 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?
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 7 Aug 2014. 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 Pei-Lung Chen (886-2-23123456 ext. 71942, paylong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B lymphocyte and T lymphocyte receptor profiles of Graves' disease patients (time frame: Three years). It is what the study was designed to measure, not a finding.
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 7 Aug 2014.