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 |
* 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
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
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
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
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
