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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005990
Receipt No. R000007087
Scientific Title Propranolol therapy for pediatric hemangioma and lymphangioma
Date of disclosure of the study information 2011/08/01
Last modified on 2019/07/23

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Basic information
Public title Propranolol therapy for pediatric hemangioma and lymphangioma
Acronym Propranolol therapy for pediatric hemangioma and lymphangioma
Scientific Title Propranolol therapy for pediatric hemangioma and lymphangioma
Scientific Title:Acronym Propranolol therapy for pediatric hemangioma and lymphangioma
Region
Japan

Condition
Condition pediatric hemangioma and lymphangioma
Classification by specialty
Surgery in general Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To asess the objective tumor response of propranolol treatment for pediatric hemangioma and lymphangioma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes objective tumor response
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 propranolol therapy
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 hemangioma and lymphangioma.
informed consent.
Key exclusion criteria Heart disease.
hypotension.
Patient who has drug allergy, and patient with the past of serious side effect by the propranolol drug.
Patient who was considered ineligible by the investigators.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Nio
Organization Tohoku University Hospital
Division name Department of Pediatric Surgery
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7237
Email mnio@ped-surg.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Taichi
Middle name
Last name Fukuzawa
Organization Tohoku University Hospital
Division name Department of Pediatric Surgery
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7237
Homepage URL
Email fukuzawa@ped-surg.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tohoku University
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel 022-717-8007
Email med-kenkyo@bureau.tohoku.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
2011 Year 08 Month 01 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 0
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 Terminated
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
2011 Year 09 Month 09 Day
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2019 Year 07 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 17 Day
Last modified on
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007087

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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