UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030336 |
|---|---|
| Receipt number | R000034646 |
| Scientific Title | Frozen autograft bone treated with liquid nitrogen for bone defect of bone and soft-tissue tumor operation |
| Date of disclosure of the study information | 2018/01/20 |
| Last modified on | 2021/09/27 11:43:42 |
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Basic information
Public title
Frozen autograft bone treated with liquid nitrogen for bone defect of bone and soft-tissue tumor operation
Acronym
Frozen autograft bone treated with liquid nitrogen
Scientific Title
Frozen autograft bone treated with liquid nitrogen for bone defect of bone and soft-tissue tumor operation
Scientific Title:Acronym
Frozen autograft bone treated with liquid nitrogen
Region
| Japan |
Condition
Condition
Malignant bone and soft tissue tumor
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of autograft bone treated with liquid nitrogen for bone and soft tissue tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ISOLS(International Society of Limb Salvage)/MSTS(Musculoskeletal Tumor Society) functional score
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
Autograft bone treated with liquid nitrogen
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
1. Malignant bone and soft tissue patients who are planned to underwent operation with bone defect at Tokushima University.
2. Malignant bone and soft tissue patients with pathological diagnosis before operation.
3. Patients with difficulty in reconstruction by tumor prosthesis.
4. Regardless of age, gender, inpatient admission or outpatient
5. Regardless of radiotherapy and chemotherapy
6. Written informed consent
Key exclusion criteria
The patients without written informed consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Nishisho |
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Division name
Department of Orthopedics
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
+81-88-633-7240
tnishisho@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Nishisho |
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Division name
Department of Orthopedics
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
+81-88-633-7240
Homepage URL
tnishisho@tokushima-u.ac.jp
Sponsor or person
Institute
Institute of Biomedical Sciences Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
N/A
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
University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics rights reserved
Address
2-50-1 Kuramoto-cho Tokushima-city Tokushima, Japan. 770-8503
Tel
088-633-9294
awachiken@tokushima-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 20 | 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
1
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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 27 | 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 | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034646
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
