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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047634
Receipt No. R000054315
Scientific Title Monitoring of microvascular and hemodynamic changes in the skin lesion with scleroderma
Date of disclosure of the study information 2022/05/09
Last modified on 2022/05/01

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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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