UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Finite Element Analysis of bones affected by bone metastases
Title of the study (Brief title)	Finite Element Analysis of bones affected by bone metastases
Region	Japan

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

Objectives
Narrative objectives1	To evaluate risk of pathologic fracture for individual bone metastases using computed tomography data and finite element method
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bone strength of the affected side relative to the other side and assumed fracture site computed using finite element method analysis
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	patients with metastatic bone tumors
Key exclusion criteria	not applicable
Target sample size	20

Research contact person
Name of lead principal investigator	Jungo Imanishi
Organization	Saitama Medical University International Medical Center
Division name	Orthopaedic Oncology and Surgery
Address	1397-1 Yamane, Hidaka, Saitama
TEL	042-984-4111
Email	jungo@saitama-med.ac.jp

Public contact
Name of contact person	Jungo Imanishi
Organization	Saitama Medical University International Medical Center
Division name	Orthopaedic Oncology and Surgery
Address	1397-1 Yamane, Hidaka, Saitama
TEL	042-984-4111
Homepage URL
Email	jungo@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 02 Month 17 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 08 Day
Anticipated trial start date	2017 Year 02 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study starts on the 8th of Feb, 2017.

Management information
Registered date	2017 Year 02 Month 08 Day
Last modified on	2017 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029935