UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029101 |
|---|---|
| Receipt number | 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 | 2023/09/19 19:15:33 |
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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 | Naomasa |
| Middle name | |
| Last name | Fukase |
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
nfukase@msn.com
Public contact
Name of contact person
| 1st name | Naomasa |
| Middle name | |
| Last name | Fukase |
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
nfukase@msn.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
| 2024 | 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
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.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 |
