UMIN-CTR Clinical Trial

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