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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038574
Receipt No. R000043960
Scientific Title Exploratory study to investigate biomarkers associated with pathogenesis of infantile hemangioma.
Date of disclosure of the study information 2019/11/13
Last modified on 2020/07/07

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Basic information
Public title Exploratory study to investigate biomarkers associated with pathogenesis of infantile hemangioma.
Acronym Exploratory study to investigate biomarkers associated with pathogenesis of infantile hemangioma.
Scientific Title Exploratory study to investigate biomarkers associated with pathogenesis of infantile hemangioma.
Scientific Title:Acronym Exploratory study to investigate biomarkers associated with pathogenesis of infantile hemangioma.
Region
Japan

Condition
Condition Infantile hemangioma
Classification by specialty
Pediatrics Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the pathogenesis of infantile hemangioma by evaluating biomarkers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Volume of infantile hemangioma in proliferating phase.
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
14 days-old <=
Age-upper limit
60 days-old >=
Gender Male and Female
Key inclusion criteria 1) Infantile hemangioma patients aged 2 weeks to 2 months with informed consent from the legally representative.
2) Patients who have not been treated for infantile hemangioma before the study.
Key exclusion criteria 1) Internal type
2) Patients who need to start treatment of infantile hemangioma before proliferating phase and the initiation of study.
3) Patients taking medications that may affect infantile hemangioma pathology and levels of biomarker before the study
4) Patients suspected of serious complications and diseases that greatly affect cytokine levels through interview by the doctors (PHACE syndrome, infection and inflammatory diseases, etc).
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Masatoshi
Middle name
Last name Jinnin
Organization Wakayama Medical University
Division name Department of Dermatology
Zip code 861-0012
Address 811-1 Kimiidera, Wakayama city, Wakayama, Japan
TEL 073-447-2300
Email mjin@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Masatoshi
Middle name
Last name Jinnin
Organization Wakayama Medical University
Division name Department of Dermatology
Zip code 861-0012
Address 811-1 Kimiidera, Wakayama city, Wakayama, Japan
TEL 073-447-2300
Homepage URL
Email mjin@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Maruho Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama city, Wakayama, Japan
Tel 073-447-2300
Email wa-rinri@wakayama-med.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 11 Month 13 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 29 Day
Date of IRB
2019 Year 10 Month 29 Day
Anticipated trial start date
2019 Year 11 Month 13 Day
Last follow-up date
2025 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information non

Management information
Registered date
2019 Year 11 Month 13 Day
Last modified on
2020 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043960

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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