Unique ID issued by UMIN | UMIN000042388 |
---|---|
Receipt number | R000048384 |
Scientific Title | Retrospective validation study for assessment of skin lesion in vascular anomalies |
Date of disclosure of the study information | 2020/11/09 |
Last modified on | 2020/11/09 13:10:02 |
Retrospective validation study for assessment of skin lesion in vascular anomalies
Retrospective validation study for assessment of skin lesion in vascular anomalies
Retrospective validation study for assessment of skin lesion in vascular anomalies
Retrospective validation study for assessment of skin lesion in vascular anomalies
Japan |
Vascular anomalies (venous malformation, lymphatic malformation, tufted angioma, kaposiform hemangioendothelioma)
Medicine in general | Hematology and clinical oncology | Surgery in general |
Pediatrics | Dermatology | Plastic surgery |
Others
NO
To establish appropriate evaluation method, we will evaluate the skin lesions by using the evaluation scores used in various diseases and evaluate the validity of these indicators.
Others
It can be an index for objectively evaluating the effectiveness of treatment in clinical trials such as drug therapy.
Correlation coefficient between the external evaluation score of the target lesion and the amount of change in the lesion volume using the "criteria for improving the skin symptoms of vascular abnormalities (size, color)", and "the skin symptoms of vascular abnormalities Correlation coefficient (co-primary endpoints) between the external evaluation score of the target lesion and the amount of change in the color tone score (PANTONE color sample scoring) using the "improvement criteria (size, color)"
Correlation between the external evaluation score of the target lesion using the criteria for improving skin symptoms of vascular abnormalities (size, color) and the amount of change in the color tone score
Correlation coefficient between the external evaluation score of the target lesion and the amount of change in the lesion volume using the criteria (size) for the degree of improvement of skin symptoms of vascular abnormalities
Correlation coefficient between the external evaluation score of the target lesion using the criteria (size) for the degree of improvement of skin symptoms of vascular abnormalities
Correlation coefficient between the external evaluation score of the target lesion using the criteria for improving skin symptoms of vascular abnormalities (color) and the amount of change in the color tone score (PANTONE color sample scoring)
Observational
Not applicable |
Not applicable |
Male and Female
1) Patients diagnosed with vascular abnormalities (venous malformations, lymphatic malformations, tufted angioma, Kaposiform hemangioendothelioma, etc.) from January 1, 2015 to December 31, 2020
2) Patients with lesions on the skin that can be evaluated by medical examination and clinical photographs
1) Patients with visceral vascular abnormalities only
2) Patients who underwent resection of the lesion during the evaluation period. However, drug therapy (including Kampo, propranolol, oral sirolimus, and topical agents) is acceptable.
3) Patients with obvious infection or inflammation at the lesion site
20
1st name | Michio |
Middle name | |
Last name | Ozeki |
Gifu University Hospital
Pediatrics
501-1194
1-1 Yanagido, Gifu City 501-1194, Japan
058-230-6000
michioo@gifu-u.ac.jp
1st name | Michio |
Middle name | |
Last name | Ozeki |
Gifu University Hospital
Pediatrics
501-1194
1-1 Yanagido, Gifu City 501-1194, Japan
058-230-6000
michioo@gifu-u.ac.jp
Gifu University
inistry of Health, Labor and Welfare
Japanese Governmental office
Gifu Univeristy
1-1 Yanagido, Gifu City 501-1194, Japan
058-230-6000
michioo@gifu-u.ac.jp
NO
2020 | Year | 11 | Month | 09 | Day |
Unpublished
Open public recruiting
2020 | Year | 09 | Month | 03 | Day |
2020 | Year | 10 | Month | 01 | Day |
2020 | Year | 10 | Month | 25 | Day |
2020 | Year | 11 | Month | 20 | Day |
Obsevertional study
2020 | Year | 11 | Month | 09 | Day |
2020 | Year | 11 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048384
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |