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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013101
Receipt No. R000014513
Scientific Title BNCT clinical trial for malignant skin tumors
Date of disclosure of the study information 2014/03/01
Last modified on 2018/10/24

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Basic information
Public title BNCT clinical trial for malignant skin tumors
Acronym BNCT for malignant skin tumors
Scientific Title BNCT clinical trial for malignant skin tumors
Scientific Title:Acronym BNCT for malignant skin tumors
Region
Japan

Condition
Condition malignant skin tumors
Classification by specialty
Dermatology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluation of the clinical results and establish of the optimal treatment shedule
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes advers event and clinical effect
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 BNCT
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
10 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1.less than 85 years old.
2.skin tumors, which precludes adequate treatment by surgery alone.
3.patients who strongly reject standard treatment.
4.recurrent tumors after primar therapy
Key exclusion criteria 1.PS is relatively better.
2.no other severe complications
3.with distant metastasis
4.superficial tumors
5.WBC:more than 3000/mm3
6.medically or socially unsuitable for this therapy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Hiratsuka
Organization Kawasaki Medical School
Division name Radiation Oncology
Zip code
Address 577 Matsushima Kurashiki
TEL 086-462-1111
Email hiratuka@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Hiratsuka
Organization Kawasaki Medical School
Division name Radiation Oncology
Zip code
Address 577 Matsushima Kurashiki
TEL 086-462-1111
Homepage URL
Email hiratuka@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Grant from Ministry of Education, Culture,Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 03 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
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 Completed
Date of protocol fixation
2013 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 07 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014513

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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