UMIN-CTR Clinical Trial

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