NCT05578105

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Jan 2022Dec 2026

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

October 10, 2022

Last Update Submit

October 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rates of endocrine organs involved

    We will observe the rate of each endocrine organ involved, including adrenal gland, thyroid, and pancreas

    2022/1/1 ~ 2026/12/31

Study Arms (1)

Autoimmune polyendocrine syndrome type II

patients with autoimmune polyendocrine syndrome type II

Other: no intervention

Interventions

No intervention, only observation

Autoimmune polyendocrine syndrome type II

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We study patients with autoimmune polyendocrine syndrome type II

You may qualify if:

  • 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.

You may not qualify if:

  • Patients aged less than 20 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Polyendocrinopathies, Autoimmune

Condition Hierarchy (Ancestors)

Endocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Shyang-Rong Shih, MD, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Shyang-Rong Shih, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations