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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Systemic sclerosis | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |