UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036380 |
|---|---|
| Receipt number | 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 14:28:40 |
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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
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
h-aiba@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Nagoya City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041450
