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UMIN-CTR Clinical Trial |
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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 | 2020/06/12 |
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 |
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Condition | ||
Condition | Malignant bone and soft tissue tumor | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | The patients without written informed consent | |||
Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |