Autoimmune Polyendocrine Syndrome Type IINCT05578105
Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan
An observational study of Autoimmune Polyendocrine Syndrome Type II, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Autoimmune polyendocrine syndrome (APS) is an autoimmune disease involving at least two endocrine organ. It is classified into type I and type II diseases. Among them, APS type II is more common. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Autoimmune Polyendocrine Syndrome Type II
- How many people
- 650 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: We study patients with autoimmune polyendocrine syndrome type II
Who may be able to join
- Patients visited NTUH during 2006-2021, and had at least two of the three diseases: type 1 DM, primary adrenal insufficiency, and autoimmune thyroid disease.
Who cannot join
- Patients aged less than 20 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Shyang-Rong Shih, MD. PhD, +886-972653337, srshih@ntu.edu.tw
About this study
Autoimmune polyendocrine syndrome (APS) is an autoimmune disease involving at least two endocrine organ. It is classified into type I and type II diseases. Among them, APS type II is more common. It is diagnosed when two of the three following diseases are diagnosed in the same patient, including type 1 diabetes mellitus, autoimmune thyroid disease, and primary adrenal insufficiency. In this study, we will observe the epidemiology, clinical characteristics, and genetic variants of APS II in Taiwan.
- Being tested
- no intervention
- Medical subject headings
- Polyendocrinopathies, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
No intervention, only observation
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune polyendocrine syndrome type II | patients with autoimmune polyendocrine syndrome type II Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of endocrine organs involved
We will observe the rate of each endocrine organ involved, including adrenal gland, thyroid, and pancreas
Measured: 2022/1/1 ~ 2026/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Polyendocrine Syndrome Type IIStudies 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
- Retrospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyang-Rong Shih, MD, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578105
- Sponsor's protocol ID
- 202112250RINC
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan
- ClinicalTrials.gov ID
- NCT05578105
- Acronym / sponsor ID
- 202112250RINC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Oct 2022 (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.
Autoimmune polyendocrine syndrome (APS) is an autoimmune disease involving at least two endocrine organ. It is classified into type I and type II diseases. Among them, APS type II is more common. It is diagnosed when two of the three following diseases are diagnosed in the same patient, including type 1 diabetes mellitus, autoimmune thyroid disease, and primary adrenal insufficiency. In this study, we will observe the epidemiology, clinical characteristics, and genetic variants of APS II in Taiwan.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autoimmune polyendocrine syndrome type II | – | Other: no interventionpatients with autoimmune polyendocrine syndrome type II |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We study patients with autoimmune polyendocrine syndrome type II
Key inclusion criteria (1 listed)
- Patients visited NTUH during 2006-2021, and had at least two of the three diseases: type 1 DM, primary adrenal insufficiency, and autoimmune thyroid disease.
Key exclusion criteria (1 listed)
- Patients aged less than 20 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionNo intervention, only observation | Other | Autoimmune polyendocrine syndrome type II |
Primary outcome
Rates of endocrine organs involved
Time frame: 2022/1/1 ~ 2026/12/31
We will observe the rate of each endocrine organ involved, including adrenal gland, thyroid, and pancreas
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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.
Shyang-Rong Shih, MD, PhD study director
National Taiwan University Hospital
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 Autoimmune Polyendocrine Syndrome Type II, 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: looking for participants now, as of the sponsor's last update on 13 Oct 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shyang-Rong Shih, MD, PhD (+886-972653337, srshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of endocrine organs involved (time frame: 2022/1/1 ~ 2026/12/31). 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 13 Oct 2022.