UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029033
Receipt number R000033032
Scientific Title A Prospective cohort study on the short and long-term prognosis, including pregnancy outcomes, of young patients with systemic lupus erythematosus in Japan.
Date of disclosure of the study information 2017/09/06
Last modified on 2019/04/25 07:06:08

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Basic information

Public title

A Prospective cohort study on the short and long-term prognosis, including pregnancy outcomes, of young patients with systemic lupus erythematosus in Japan.

Acronym

Prospective cohort study of young SLE in Japan

Scientific Title

A Prospective cohort study on the short and long-term prognosis, including pregnancy outcomes, of young patients with systemic lupus erythematosus in Japan.

Scientific Title:Acronym

Prospective cohort study of young SLE in Japan

Region

Japan


Condition

Condition

systemic lupus erythematosus.

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the short and long- term prognosis, including pregnancy outcomes, of young systemic lupus erythematosus patients in Japan.

Basic objectives2

Others

Basic objectives -Others

To clarify the effects of long-term SLE medical treatment on the psychological aspects and quality of life of SLE patients.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of relapse of original disease and morbidity in 5, 10, 20 year periods after SLE diagnosis.

Key secondary outcomes

Pregnancy outcome after diagnosis of SLE.


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

6 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

Young patients between 6 and 40 years of age who have been newly diagnosed with SLE.

Key exclusion criteria

The patients who are difficult to contact with researchers and undergo the annual check.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Murashima
Middle name
Last name Atsuko

Organization

National Center for Child Health and Development

Division name

Center of Maternal-Fetal, Neonatal and Reproductive Medicine

Zip code

157-8535

Address

2-10-1, Okura Setagaya, Tokyo, Japan

TEL

0334160181

Email

murasima-a@ncchd.go.jp


Public contact

Name of contact person

1st name Kayoko
Middle name
Last name Kaneko

Organization

National Center for Child Health and Development

Division name

Center of Maternal-Fetal, Neonatal and Reproductive Medicine

Zip code

157-8535

Address

2-10-1, Okura Setagaya, Tokyo, Japan

TEL

0334160181

Homepage URL


Email

kaneko-ky@ncchd.go.jp


Sponsor or person

Institute

National Center for Child Health and Development

Institute

Department

Personal name



Funding Source

Organization

Japan College of Rheumatology

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

National Center for Child Health and Development

Address

2-10-1, Okura, Setagaya-ku

Tel

0334160181

Email

rinri@ncchd.go.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

2017 Year 09 Month 06 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

Open public recruiting

Date of protocol fixation

2017 Year 08 Month 07 Day

Date of IRB

2017 Year 08 Month 04 Day

Anticipated trial start date

2017 Year 11 Month 13 Day

Last follow-up date

2034 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2017 Year 09 Month 06 Day

Last modified on

2019 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033032


Research Plan
Registered date File name
2017/09/06 ②研究計画書_若年SLE前向き研究_20170727最新修正.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name