UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
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	2023 Year 01 Month 20 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	2020 Year 06 Month 12 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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