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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030336
Receipt No. 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 2018/08/07

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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
Middle name
Last name Toshihiko Nishisho
Organization Institute of Biomedical Sciences Tokushima University Graduate School
Division name Department of Orthopedics
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL +81-88-633-7240
Email tnishisho@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Nishisho
Organization Institute of Biomedical Sciences Tokushima University Graduate School
Division name Department of Orthopedics
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL +81-88-633-7240
Homepage URL
Email tnishisho@tokushima-u.ac.jp

Sponsor
Institute Institute of Biomedical Sciences Tokushima University Graduate School
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 20 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
2017 Year 12 Month 10 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034646

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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