UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016044 |
|---|---|
| Receipt number | R000018648 |
| Scientific Title | Image guided cryoablation for malignant bone and soft tissue tumor |
| Date of disclosure of the study information | 2014/12/26 |
| Last modified on | 2014/12/24 13:50:59 |
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Basic information
Public title
Image guided cryoablation for malignant bone and soft tissue tumor
Acronym
Cryoablation for malignant bone and soft tissue tumor
Scientific Title
Image guided cryoablation for malignant bone and soft tissue tumor
Scientific Title:Acronym
Cryoablation for malignant bone and soft tissue tumor
Region
| Japan |
Condition
Condition
Recurrent or metastatic bone and soft tissue tumors
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the clinical outcome of image guided cryoablation for malignant bone and soft tissue tumors to elucidate the problems surrounding this procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Effectiveness against the tumor will be analyzed at 1 month after treatment and every 3 month afterward using Xp, CT, and MRI. Pain will be assessed prior to the treatment, 1 day and 1 week after the treatment, and every 3 month afterward using the VAS.
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
| Maneuver |
Interventions/Control_1
Recurrent or metastatic bone and soft tissue tumor
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
Recurrent or metastatic bone and soft tissue tumor
Key exclusion criteria
1. Cases with coagulation disorder or hemorrhagic tendency.
2. Lesions that are adjacent to vital organs.
3. Cases with systemic or local infection near the treatment site.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Morioka |
Organization
Keio University School of Medicine
Division name
Department of orthopaedic surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3812
morioka@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Morioka |
Organization
Keio University School of Medicine
Division name
Department of orthopaedic surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3812
Homepage URL
morioka@z3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Non applicable
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
Address
Tel
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 | 12 | Month | 26 | 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
| 2011 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 24 | Day |
Last modified on
| 2014 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018648
