UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042804 |
|---|---|
| Receipt number | R000048685 |
| Scientific Title | A survey of vitamin D status in Japanese patients with multiple myeloma |
| Date of disclosure of the study information | 2021/01/10 |
| Last modified on | 2021/06/25 13:10:35 |
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Basic information
Public title
A survey of vitamin D status in Japanese patients with multiple myeloma
Acronym
A survey of vitamin D status in Japanese patients with multiple myeloma
Scientific Title
A survey of vitamin D status in Japanese patients with multiple myeloma
Scientific Title:Acronym
A survey of vitamin D status in Japanese patients with multiple myeloma
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Observational survey of the relationship between serum vitamin D level and survival in Japanese patients with multiple myeloma
Basic objectives2
Others
Basic objectives -Others
Observational survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
EQ-5D
skeletal morbidity
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
Multiple myeloma patients treated at Department of Hematology, NishiGunma Hospital from November 2015 to December 2016
Key exclusion criteria
Patients who have been judged by the investigator to be inappropriate for participation in this survey
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Isoda |
Organization
Shibukawa medical center
Division name
Department of Hematology
Zip code
377-0280
Address
Shirai 383, Shibukawa, Gunma
TEL
0279231010
hoshiclinic01@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Isoda |
Organization
Shibukawa medical center
Division name
Department of Hematology
Zip code
377-0280
Address
Shirai 383, Shibukawa, Gunma
TEL
0279231010
Homepage URL
hoshiclinic01@gmail.com
Sponsor or person
Institute
Shibukawa medical center
Institute
Department
Personal name
Funding Source
Organization
Shibukawa medical center
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
Shibukawa medical center
Address
Shirai 383, Shibukawa, Gunma
Tel
0279231010
hoshiclinic01@gmail.com
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
| 2021 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://site2.convention.co.jp/46jsm/program.html
Number of participants that the trial has enrolled
80
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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For patients who are deficient in serum vitamin D, we will take appropriate measures such as nutritional guidance.
Management information
Registered date
| 2020 | Year | 12 | Month | 21 | Day |
Last modified on
| 2021 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048685
