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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035915
Receipt No. 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 2019/08/20

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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
Email 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
Email rinri@gifu-u.ac.jp

Sponsor
Institute ARTham Therapeutics Inc
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040912

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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