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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044578
Receipt No. R000050900
Scientific Title Epidemiological study of childhood-onset systemic sclerosis and localized scleroderma
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/17

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Basic information
Public title Epidemiological study of childhood-onset systemic sclerosis and localized scleroderma
Acronym Epidemiological study of childhood-onset scleroderma
Scientific Title Epidemiological study of childhood-onset systemic sclerosis and localized scleroderma
Scientific Title:Acronym Epidemiological study of childhood-onset scleroderma
Region
Japan

Condition
Condition Systemic sclerosis
Localized scleroderma
Classification by specialty
Clinical immunology Pediatrics Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the prevalence of patients with childhood-onset systemic sclerosis and localized scleroderma in Japan.
Basic objectives2 Others
Basic objectives -Others To investigate the clinical features of patients with childhood-onset systemic sclerosis and localized scleroderma.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The prevalence of patients with childhood-onset systemic sclerosis and localized scleroderma in Japan.
Key secondary outcomes Clinical features of patients with childhood-onset systemic sclerosis and localized scleroderma.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients (both in-patients and out-patients) are admitted to the hospital from January 2016 to December 2020, and are eligible for inclusion in the registry if they experienced the onset of systemic sclerosis or localized scleroderma prior to age 18 years and whatever their age at enrollment.
Key exclusion criteria Persons who are judged to be ineligible for this study by the principal investigator.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Fujimoto
Organization Osaka University
Division name Department of DermatologyDermatology
Zip code 5650871
Address Yamadaoka 2-2, Suita, Osaka
TEL +81668793032
Email fujimoto@derma.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Ikuko
Middle name
Last name Ueda
Organization Osaka University
Division name Department of Dermatology
Zip code 5650871
Address Yamadaoka 2-2, Suita, Osaka
TEL 0668793032
Homepage URL
Email iueda@derma.med.osaka-u.ac.jp

Sponsor
Institute The study group for "Diagnostic criteria, severity classification, guideline, patient registry of systemic sclerosis and cutaneous fibrotic diseases"
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare of Japan, funds for research on intractable diseases
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Board of Osaka University Hospital
Address Yamadaoka 2-2, Suita, Osaka
Tel +81-6-6210-8296
Email rinri-jim@dmi.med.osaka-u.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
2021 Year 07 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
2021 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective observational study

Management information
Registered date
2021 Year 06 Month 17 Day
Last modified on
2021 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050900

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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