UMIN-CTR Clinical Trial

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
Email	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
Email	mori.phv@tmd.ac.jp

Sponsor
Institute	Ministry of Health, Labor and Welfare
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033213