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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029101
Receipt No. R000033116
Scientific Title The safety and efficacy of transcutaneous carbon dioxide (CO2) application for malignant bone and soft tissue tumor (sarcoma)
Date of disclosure of the study information 2017/11/01
Last modified on 2019/03/15

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Basic information
Public title The safety and efficacy of transcutaneous carbon dioxide (CO2) application for malignant bone and soft tissue tumor (sarcoma)
Acronym Transcutaneous carbon dioxide (CO2) application for malignant bone and soft tissue tumor (sarcoma)
Scientific Title The safety and efficacy of transcutaneous carbon dioxide (CO2) application for malignant bone and soft tissue tumor (sarcoma)
Scientific Title:Acronym Transcutaneous carbon dioxide (CO2) application for malignant bone and soft tissue tumor (sarcoma)
Region
Japan

Condition
Condition Malignant bone and soft tissue tumor
Sarcoma
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and the efficacy of transcutaneous carbon dioxide (CO2) application on malignant bone and soft tissue tumors
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes complication
Key secondary outcomes antitumor effect
local blood flow

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
Device,equipment
Interventions/Control_1 Transcutaneous carbon dioxide (CO2) application
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients who have been histologically
diagnosed as either malignant bone tumor or malignant soft tissue tumor.
(2) Age 16 yo or more
(3) More than 4 weeks since any prior therapy
(4) PS 0-1
(5) The patient have consented to the study in the document
Key exclusion criteria (1) Skin ulcer or pathological fracture in the
treated area
(2) Peripheral arterial disease or ischemic disease in the affected limb
(3) Skin disease in the affected limb
(4) Active infectious disease in the affected limb
(5) Other medical or psychological unsuitable reasons
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Teruya
Middle name
Last name Kawamoto
Organization Kobe University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 6500017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017 JAPAN
TEL 078-382-5985
Email trykwmt@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Teruya
Middle name
Last name Kawamoto
Organization Kobe University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 6500017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017 JAPAN
TEL 078-382-5985
Homepage URL
Email trykwmt@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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 Institutional Review Board, Kobe University Hospital Clinical Translational Research Center
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017 JAPAN
Tel 078-382-6669
Email ccrspprt@med.kobe-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 神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 11 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 18 Day
Date of IRB
2018 Year 02 Month 26 Day
Anticipated trial start date
2018 Year 02 Month 26 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 12 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033116

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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