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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031826
Receipt No. R000036306
Scientific Title Research for the association of enhanced osteogenesis of hyperthermia for artificial bone grafting after resection of metastatic bone tumor
Date of disclosure of the study information 2018/06/01
Last modified on 2018/03/21

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Basic information
Public title Research for the association of enhanced osteogenesis of hyperthermia for artificial bone grafting after resection of metastatic bone tumor
Acronym Research for the association of enhanced osteogenesis of hyperthermia for artificial bone grafting after resection of metastatic bone tumor
Scientific Title Research for the association of enhanced osteogenesis of hyperthermia for artificial bone grafting after resection of metastatic bone tumor
Scientific Title:Acronym Research for the association of enhanced osteogenesis of hyperthermia for artificial bone grafting after resection of metastatic bone tumor
Region
Japan

Condition
Condition metastatic bone tumor
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the Therapeutic effect of combination with curettage, artificial bone transplantation and selective hyperthermia for metastatic bone tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Antitumor effect and osteogenesis
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
Medicine Maneuver
Interventions/Control_1 tumor curettage, artificial bone transplantation, selective hyperthermia
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria It is diagnosed as metastatic bone tumors
Do not worry about pathological fracture immediately
Key exclusion criteria Radiotherapy was already performed
There are some implanted device made from magnetic material
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Nishida
Organization Nagoya University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-741-2111
Email ynishida@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Ota
Organization Nagoya University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-741-2111
Homepage URL
Email takeota@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagoya City University
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 06 Month 01 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 03 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 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
2018 Year 03 Month 21 Day
Last modified on
2018 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036306

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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