UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000051753
Receipt number R000059066
Scientific Title Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease
Date of disclosure of the study information 2023/07/30
Last modified on 2024/04/08 16:13:57

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Basic information

Public title

Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease

Acronym

Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease

Scientific Title

Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease

Scientific Title:Acronym

Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease

Region

Japan


Condition

Condition

Autoimmune thyroid disease

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the differences in the severity of exophthalmos in Japanese patients with autoimmune thyroid disease depend on whether a patient has a severe myopia,or histories of somoking and/or steroid use. We also evaluate exophthalmos in Japanese people without autoimmune thyroid disease to determine the normal range of exophthalmos in Japanese people.

Basic objectives2

Others

Basic objectives -Others

We evaluate the differences in the severity of exophthalmos in Japanese patients with autoimmune thyroid disease depend on whether a patient has a severe myopia,or histories of somoking and/or steroid use. We also evaluate exophthalmos in Japanese people without autoimmune thyroid disease to determine the normal range of exophthalmos in Japanese people.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Exophthalmos determined by Hertel's ptectometer.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

12 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with autoimmune thyroid disease(Graves disease and Hashimoto thyroiditis)
2) People without autoimmune thyroid disease

Key exclusion criteria

Patient with histories of ophthic surgery.

Target sample size

1300


Research contact person

Name of lead principal investigator

1st name Ichiro
Middle name
Last name Horie

Organization

Nagasaki University

Division name

Endocrinology and Metabolism

Zip code

8528501

Address

1-7-1Sakamoto, Nagasaki

TEL

0958197262

Email

horie@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Ichiro
Middle name
Last name Horie

Organization

Nagasaki University

Division name

Endocrinology and Metabolism

Zip code

8528501

Address

1-7-1Sakamoto, Nagasaki

TEL

0958197262

Homepage URL


Email

horie@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Review board of clinical research at Nagasaki University Hospital

Address

1-7-1 Sakamoto, Nagasaki

Tel

0958197262

Email

horie@nagasaki-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 07 Month 30 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023 Year 07 Month 30 Day

Date of IRB

2023 Year 08 Month 29 Day

Anticipated trial start date

2023 Year 09 Month 01 Day

Last follow-up date

2026 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2023 Year 07 Month 30 Day

Last modified on

2024 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059066