UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between upper gastrointestinal tumors and the amount of skin carotenoids
Acronym	The relationship between upper gastrointestinal tumors and the amount of skin carotenoids
Scientific Title	The relationship between upper gastrointestinal tumors and the amount of skin carotenoids
Scientific Title:Acronym	The relationship between upper gastrointestinal tumors and the amount of skin carotenoids
Region	Japan

Condition
Condition	Gastrointestinal disease
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the relationship between upper gastrointestinal tumors (duodenum, stomach, esophagus, pharynx, larynx) and skin carotenoid levels
Basic objectives2	Others
Basic objectives -Others	Skin carotenoid level
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Skin carotenoid level,
Key secondary outcomes	Age, gender, primary disease, medical history,family history, oral medicine history, weight, height, alcohol drinking habit, flushing, smoking, vegetable intake, fruit intake, living habits (family composition, marriage, dietary habit)

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	Patients who are visiting or hospitalized in the Department of Gastroenterology, Toranomon Hospital for upper gastrointestinal tumors (atypical epithelium or cancer of the duodenum, stomach, esophagus, pharynx, larynx).
Key exclusion criteria	1.Those who did not agree to participate in this study. 2.Those who participated in another research during the study period. 3.Those who cannot measure the skin using Vegecheck due to scratches on the measurement site of the palm. 4.Those who have undergone upper gastrointestinal surgery. 5.Those who have been hospitalized within the past month or who have had restrictions on dietary intake.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Kikuchi
Organization	Toranomon hospital
Division name	Department of Gastroenterology
Zip code	105-8470
Address	2-2-2, Toranomon, Minato, Tokyo
TEL	03-3588-1111
Email	dkiku1230@gmail.com

Public contact
Name of contact person	1st name Junnosuke Middle name Last name Hayasaka
Organization	Toranomon hospital
Division name	Department of Gastroenterology
Zip code	105-8470
Address	2-2-2, Toranomon, Minato, Tokyo
TEL	03-3588-1111
Homepage URL
Email	bandwagondane@gmail.com

Sponsor
Institute	Toranomon hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kagome CO. LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee of Toranomon Hospital
Address	2-2-2, Toranomon, Minato, Tokyo
Tel	03-3588-1111
Email	chiken-jim@toranomon.gr.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2021-R05
Org. issuing International ID_1	Kagome Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	虎の門病院（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 29 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	2021 Year 07 Month 07 Day
Date of IRB	2021 Year 07 Month 07 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design: Prospective cohort observational study Subject: Patients who visit our facility or are hospitalized from October 2021 to January 2022 and meet the selection criteria Assessment: skin carotenoid level, primary disease, medical history, age, gender, family history, oral medicine history, weight, height, alcohol drinking habit, flushing, smoking, vegetable intake, fruit intake, living habits (family composition, marriage, dietary habit)

Management information
Registered date	2021 Year 10 Month 28 Day
Last modified on	2021 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052044