UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring of microvascular and hemodynamic changes in the skin lesion with scleroderma
Acronym	Monitoring of microvascular and hemodynamic changes in the skin lesion with scleroderma
Scientific Title	Monitoring of microvascular and hemodynamic changes in the skin lesion with scleroderma
Scientific Title:Acronym	Monitoring of microvascular and hemodynamic changes in the skin lesion with scleroderma
Region	Japan

Condition
Condition	Systemic sclerosis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Correlation between a quantitative evaluation method by raster scanning photoacoustic mesoscope (RSOM) and conventional evaluation methods such as skin scores, vascular findings in nail folds, organ complications, and immune abnormalities in patients with scleroderma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between raster scanning optoacoustic mesoscopy (RSOM) findings and skin scores in patients with scleroderma.
Key secondary outcomes	Correlation between raster scanning optoacoustic mesoscopy (RSOM) findings and organ complications in patients with scleroderma. Differences in raster scanning optoacoustic mesoscopy (RSOM) findings among healthy controls and patients with scleroderma and other connective tissue disorders.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Raster scanning photoacoustic mesoscope (RSOM)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with scleroderma and other connective tissue disorders
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shunichi Middle name Last name Fujita
Organization	Kawasaki Medical School
Division name	Department of Rheumatology
Zip code	701-0192
Address	577 Matsushima, Kurashiki-City, Okayama
TEL	0864621111
Email	shunichi@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Shunichi Middle name Last name Fujita
Organization	Kawasaki Medical School
Division name	Department of Rheumatology
Zip code	701-0192
Address	577 Matsushima, Kurashiki-City, Okayama
TEL	0864621111
Homepage URL
Email	shunichi@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kawasaki Medical School Ethics Review Board
Address	577 Matsushima, Kurashiki-City, Okayama
Tel	0864621111
Email	kmsrec@med.kawasaki-m.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	2022 Year 05 Month 09 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	2022 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 09 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 01 Day
Last modified on	2022 Year 05 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054315

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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