UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014527
Receipt number R000016894
Scientific Title To evaluate the mechanism of anti TSH-receptor antibody production in patients with untreated Graves' disease.
Date of disclosure of the study information 2014/07/14
Last modified on 2015/01/16 23:39:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

To evaluate the mechanism of anti TSH-receptor antibody production in patients with untreated Graves' disease.

Acronym

To evaluate the mechanism of anti TSH-receptor antibody production in patients with untreated Graves' disease.

Scientific Title

To evaluate the mechanism of anti TSH-receptor antibody production in patients with untreated Graves' disease.

Scientific Title:Acronym

To evaluate the mechanism of anti TSH-receptor antibody production in patients with untreated Graves' disease.

Region

Japan


Condition

Condition

Graves' disease

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the mechanism of anti TSH-receptor antibody production in patients with untreated Graves' disease.

Basic objectives2

Others

Basic objectives -Others

To identify the molecules which regulate anti TSH-receptor antibody production.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Anti TSH-receptor antibody production from isolated B cell of patients with untreated Graves disease are stimulated by verious factors.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

To isolate B cell from whole blood sample from patients with untreated Graves' disease.

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with untreated Graves disease who come to Juntendo unversity hospital.

Key exclusion criteria

1) Patients with congenital immunodeficiency.
2) Patients who are treated with immunosuppressant or biologics.
3) Patients with other autoimmune disease or chronic inflammatory disease.
4) Pregnant or lactating women.
5) Patients who are at the age of <20y.o. or >=80y.o.
6) Patients who lack judgment to attend this study in social or medical aspect.
7) Patients who disagree with this study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toyoyoshi Uchida

Organization

Juntendo University Graduate School of Medicine

Division name

Departments of Metabolism & Endocrinology

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan

TEL

03-5802-1579

Email

uchitoyo@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toyoyoshi Uchida

Organization

Juntendo University Graduate School of Medicine

Division name

Departments of Metabolism & Endocrinology

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan

TEL

03-5802-1579

Homepage URL


Email

uchitoyo@juntendo.ac.jp


Sponsor or person

Institute

Departments of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Departments of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 07 Month 14 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

2014 Year 06 Month 20 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 07 Month 10 Day

Last modified on

2015 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016894


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name