UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035915 |
|---|---|
| Receipt number | R000040912 |
| Scientific Title | A pathogenic mosaic mutation analysis of the Japanese patients with vascular malformations |
| Date of disclosure of the study information | 2019/02/18 |
| Last modified on | 2020/02/20 13:58:28 |
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Basic information
Public title
A pathogenic mosaic mutation analysis of the Japanese patients with vascular malformations
Acronym
A mutation analysis of vascular malformations
Scientific Title
A pathogenic mosaic mutation analysis of the Japanese patients with vascular malformations
Scientific Title:Acronym
A mutation analysis of vascular malformations
Region
| Japan |
Condition
Condition
Vascular malformations and PIK3CA-related Overgrouwht Spectrum
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Surgery in general |
| Vascular surgery | Pediatrics | Dermatology |
| Orthopedics | Radiology | Plastic surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
A pathogenic mosaic mutations analysis of the Japanese patients with vascular malformations and PROS(PIK3CA-related overgrowth Spectrum)
Basic objectives2
Others
Basic objectives -Others
A rate of mutation of vascular malformations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A pathogenic mosaic mutations analysis of the Japanese patients with vascular malformations and PROS(PIK3CA-related overgrowth Spectrum)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Vascular malformations, PROS (PIK3CA-related overgrowth spectrum)
Key exclusion criteria
Other vascular malformations (lymphedema, HHT or familial vascular malformations)
Known history of HBV, HCV, HTLV and HIV infection
Patient who is judged inappropriate to participate in this study by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ozeki |
| Middle name | |
| Last name | Michio |
Organization
Gifu University Hospital
Division name
Pediatrics
Zip code
501-1194
Address
1-1 Yanagido, Gifu City 501-1194, Japan
TEL
058-230-6386
michioo@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Ozeki |
Organization
Gifu University
Division name
Medical department
Zip code
501-1194
Address
1-1 Yanagido, Gifu City 501-1194, Japan
TEL
058-230-6059
Homepage URL
rinri@gifu-u.ac.jp
Sponsor or person
Institute
ARTham Therapeutics Inc
Institute
Department
Personal name
Funding Source
Organization
ARTham Therapeutics Inc
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Child Health and Development
Shinshu University
Osaka University
Oita University
Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University
Address
1-1 Yanagido, Gifu City 501-1194, Japan
Tel
058-230-6059
rinri@gifu-u.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
| 2019 | Year | 02 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will perform the pathogenic mosaic mutation analysis of the patients with vascular malformations.
Management information
Registered date
| 2019 | Year | 02 | Month | 18 | Day |
Last modified on
| 2020 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040912
| Research Plan | |
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| 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 |
