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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036380
Receipt No. R000041450
Scientific Title Prospective Study of the skeletal related events for the patients with bone metastasis
Date of disclosure of the study information 2020/04/01
Last modified on 2019/04/02

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Basic information
Public title Prospective Study of the skeletal related events for the patients with bone metastasis
Acronym Prospective Study of SREs for bone metastasis
Scientific Title Prospective Study of the skeletal related events for the patients with bone metastasis
Scientific Title:Acronym Prospective Study of SREs for bone metastasis
Region
Japan

Condition
Condition Patients with bone metastasis
Classification by specialty
Medicine in general Orthopedics Radiology
Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The high-rate incidence of bone metastasis is reported for advanced cancers. Skeletal-related events (SREs) sometimes occurs and the management of the prevention is considered to be important for maintenance of QOL.
Basic objectives2 Others
Basic objectives -Others Investigation of the relationships between SREs and the bone density/ bone turnover makers.
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of incidence of SREs
Key secondary outcomes Bone density, Bone turnover markers, Vitamin D

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
80 years-old >=
Gender Male and Female
Key inclusion criteria With bone metastasis
Concent to this study
Performance status 1-3
Key exclusion criteria Cancer with unknown origin
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hisaki
Middle name
Last name Aiba
Organization Nagoya City University
Division name Department of Orthopaedic Surgery
Zip code 467-8601
Address 1, Azakawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL 052-853-8236
Email h-aiba@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Hisaki
Middle name
Last name Aiba
Organization Nagoya City University
Division name Department of Orthopaedic Surgery
Zip code 467-8601
Address 1, Azakawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL 052-853-8236
Homepage URL
Email h-aiba@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Nagoya City University
Institute
Department

Funding Source
Organization Self funding
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 Clinical Research Management Center, Nagoya City University Hospital
Address 1, Azakawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
Tel 052-851-5511
Email clinical_research@med.nagoya-cu.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
2020 Year 04 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
2019 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2029 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not otherwise special

Management information
Registered date
2019 Year 04 Month 02 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041450

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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