UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047634 |
|---|---|
| Receipt number | 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 | 2023/05/02 21:05:34 |
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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
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
shunichi@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 22 | Day |
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
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054315
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
