UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040023 |
|---|---|
| Receipt number | R000045629 |
| Scientific Title | Cryoablation for bone metastasis |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/04/01 12:34:40 |
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Basic information
Public title
Cryoablation for bone metastasis
Acronym
Cryoablation for bone metastasis
Scientific Title
Cryoablation for bone metastasis
Scientific Title:Acronym
Cryoablation for bone metastasis
Region
| Japan |
Condition
Condition
Metastatic bone tumor
Classification by specialty
| Surgery in general | Chest surgery | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Palliative treatment for metastatic bone tumor causing pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Pain relieving effect.
Key secondary outcomes
Complication,prognosis.
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Metastatic bone tumor causing pain, which could be approached by cryoproge.
Key exclusion criteria
The bone tumor which cannot be approached by cryoprobe.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nomori |
| Middle name | |
| Last name | Hiroaki |
Organization
kashiwa Kousei General Hospital
Division name
Thoracic surgery
Zip code
277-8551
Address
617 Shikoda, Kashiwa City, Chiba
TEL
0471-45-1111
hnomori@qk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Nomori |
| Middle name | |
| Last name | Hiroaki |
Organization
kashiwa Kousei General Hospital
Division name
Thoracic surgery
Zip code
277-8551
Address
617 Shikoda, Kashiwa City, Chiba
TEL
0471-45-1111
Homepage URL
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kashiwa Kousei General Hospital,
Thoracic Surgery
Institute
Department
Personal name
Funding Source
Organization
Kashiwa Kousei General Hospital,
Thoracic Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kashiwa Kousei General Hospital
Address
617 Shikoda, Kashiwa City, Chiba
Tel
0471-45-1111
hnomori@qk9.so-net.ne.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
| 2020 | Year | 04 | 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
| 2020 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is nothing particular.
Management information
Registered date
| 2020 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045629
