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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029034
Receipt No. 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 2017/09/06

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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
0 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
Middle name
Last name Masaaki Mori
Organization Tokyo Medical and Dental University
Division name Department of Lifetime Clinical Immunology, Graduate School of Medical and Dental Sciences
Zip code
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
Middle name
Last name Masaaki Mori
Organization Tokyo Medical and Dental University
Division name Department of Lifetime Clinical Immunology, Graduate School of Medical and Dental Sciences
Zip code
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
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
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
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
2017 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.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


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