UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048445 |
|---|---|
| Receipt number | R000052336 |
| Scientific Title | Study on the rate of thiamine deficiency and related factors in outpatient cancer patients |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/07/24 20:08:44 |
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Basic information
Public title
Study on the rate of thiamine deficiency and related factors in outpatient cancer patients
Acronym
Study on the rate of thiamine deficiency and related factors in outpatient cancer patients
Scientific Title
Study on the rate of thiamine deficiency and related factors in outpatient cancer patients
Scientific Title:Acronym
Study on the rate of thiamine deficiency and related factors in outpatient cancer patients
Region
| Japan |
Condition
Condition
Various types of cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate and analyze the frequency and associated factors of vitamin B1 (thiamine, hereafter VB1) deficiency in patients attending hospitals for cancer.
Basic objectives2
Others
Basic objectives -Others
It will be possible to prevent VB1 deficiency disorders such as Wernicke's encephalopathy and other brain and nerve disorders and heart failure caused by VB1 deficiency.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient examination findings and measurement of blood thiamine levels during the study period.
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
All cancer patients who are attending Mitsubishi Kyoto Hospital for outpatient oncology, palliative care, or breast surgery during the study period and are scheduled to undergo blood sampling, and who agree to cooperate in the research.
Key exclusion criteria
Patients deemed inappropriate by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Yoshioka |
Organization
Mitsubishi Kyoto Hospital
Division name
Department of Oncology and Palliaitve care
Zip code
615-8087
Address
Goshiomachi1 Katsura Nishikyo-ku Kyoto Japan
TEL
075-381-2111
akira1.yoshioka@mitsubishi-motors.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yoshioka |
Organization
Mitsubishi Kyoto Hospital
Division name
Department of Oncology and Palliaitve care
Zip code
615-8087
Address
Goshiomachi1 Katsura Nishikyo-ku Kyoto Japan
TEL
075-381-2111
Homepage URL
akirayosak@mac.com
Sponsor or person
Institute
Mitsubishi Kyoto Hospital
Department of Oncology and Palliaitve care
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Psycho-oncology, Saitama Medical University International Medical Center
Department of Clinical Epidemiology, Graduate School of Biomedical Sciences, Nagasaki University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mitsubishi Kyoto Hospital
Address
Goshiomachi1 Katsura Nishikyo-ku Kyoto Japan
Tel
075-381-2111
mkhp@mitsubishi-hp.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
三菱京都病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | 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
128
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
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 24 | Day |
Last modified on
| 2022 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052336
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
