UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029034 |
|---|---|
| Receipt number | R000033213 |
| Scientific Title | Analysis of nationwide survey data of pediatric rheumatic diseases in childhood and adult transition and homogeneity of standard treatment by construction of a nationwide "seamless" medical care network based on the dissimilarity of both |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2019/09/16 14:43:49 |
* 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
Analysis of nationwide survey data of pediatric rheumatic diseases in childhood and adult transition and homogeneity of standard treatment by construction of a nationwide "seamless" medical care network based on the dissimilarity of both
Acronym
Analysis of nationwide survey data of pediatric rheumatic diseases and nationwide "seamless" medical care network construction
Scientific Title
Analysis of nationwide survey data of pediatric rheumatic diseases in childhood and adult transition and homogeneity of standard treatment by construction of a nationwide "seamless" medical care network based on the dissimilarity of both
Scientific Title:Acronym
Analysis of nationwide survey data of pediatric rheumatic diseases and nationwide "seamless" medical care network construction
Region
| Japan |
Condition
Condition
Juvenile idiopathic arthritis (JIA), systemic lupus erythematosus (SLE), juvenile dermatomyositis (JDM), Sjogren's syndrome (SS) in childhood to adult transition
Classification by specialty
| Clinical immunology | Pediatrics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Based on the results of the national survey of JIA, SLE, JDM, SS conducted from pediatric to adult transition period in preliminary research, 1)actual condition of clinical practice in childhood and adult transition, 2)verification of the validity of conventional classification standards, 3) long-term observation from childhood to adult transition, verification of prognostic factors leading to remission or dysfunction, 4)collecting basic data for database supplementation based on the process to diagnosis, treatment and medication contents, 5)examination of problems related to pregnancy, we will verify the differences between children and adults diversely and compare children with local circumstances Establishing a seamless medical care system from the term to the adult transition period, and establishing a national medical care network.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Five examinations of the following subjects; 1)actual condition of clinical practice in childhood and adult transition, 2)verification of the validity of conventional classification standards, 3) long-term observation from childhood to adult transition, verification of prognostic factors leading to remission or dysfunction, 4)collecting basic data for database supplementation based on the process to diagnosis, treatment and medication contents, 5)examination of problems related to pregnancy
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
| 1 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients of all ages from children to adults who are diagnosed and treated at JIC, SLE, JDM, SS based on the diagnostic criteria of the Ministry of Health, Labor and Welfare, at the facility where research director, cooperative researcher, research assistant belongs
Key exclusion criteria
Cases in which it is difficult to definitely diagnose the rheumatic disease from clinical course and treatment contents from the medical record
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Mori |
Organization
Tokyo Medical and Dental University
Division name
Department of Lifetime Clinical Immunology, Graduate School of Medical and Dental Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-4876
mori.phv@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Mori |
Organization
Tokyo Medical and Dental University
Division name
Department of Lifetime Clinical Immunology, Graduate School of Medical and Dental Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-4876
Homepage URL
mori.phv@tmd.ac.jp
Sponsor or person
Institute
Ministry of Health, Labor and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
+81-3-3813-6111
mori.phv@tmd.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
| 2017 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
*Creation of correspondence table (research subject identification code list):
Yes
*Information on medical records to be acquired: information on age, sex, presence or absence of arthritis and number of affected joints, duration of disease, duration of illness, fever, heat type, presence, absence of systemic symptoms, skin symptoms, adhesion flame, iritis, presence of uveitis, rheumatoid Factor, antinuclear antibody titer, contents of drug treatment, disease activity and physical function, working situation etc.
*Sample to be used: Type of information: patient serum, amount: about 0.5 - 1.0 ml,Collection method: residual serum obtained by clinical routine bleeding,Required time: When examining the details of diagnosis, treatment, disease activity, evaluation method and prognostic judgment
Management information
Registered date
| 2017 | Year | 09 | Month | 06 | Day |
Last modified on
| 2019 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033213
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
