UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038574
Receipt number 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 2022/11/15 18:02:02

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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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

45

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 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

2022 Year 12 Month 31 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

2022 Year 11 Month 15 Day



Link to view the page

Value
https://center6.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