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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048445
Receipt No. 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

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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
Email 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
Email akirayosak@mac.com

Sponsor
Institute Mitsubishi Kyoto Hospital
Department of Oncology and Palliaitve care
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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