UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploring the association between upper gastrointestinal disease and chronotype: a multicenter study in Japan
Title of the study (Brief title)	Association between upper gastrointestinal disease and chronotype
Region	Japan

Condition
Condition	upper gastrointestinal disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association between upper gastrointestinal disease and chronotype.
Basic objectives2	Others
Basic objectives -Others	This study could elucidate upper gastrointestinal disease and provide new treatment.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of the chronotype of gastrointestinal disease
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	1. Male or female aged >= 20 years 2. Patients performed esophagogastroduodenoscopy within a year 3. Patients with informed consent
Key exclusion criteria	1. Patients taking hypnotic on a daily basis 2. Patients with severe heart, lung, liver, and kidney disease 3. Patients with severe psychiatric disease such as depression, drug dependency, and alcohol dependency 4. Patients following shift working 5. Patients in pregnancy or breast-feeding 6. Patients judged by the investigators as incompatibility with the study.
Target sample size	1500

Research contact person
Name of lead principal investigator	Jun Nishikawa
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Laboratory Science
Address	Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL	0836-22-2835
Email	junnis@yamaguchi-u.ac.jp

Public contact
Name of contact person	Jun Nishikawa
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Laboratory Science
Address	Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL	0836-22-2835
Homepage URL
Email	junnis@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Laboratory Science, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	周東総合病院 国立国際医療研究センター病院 がん研有明病院 国立病院機構東京医療センター 群馬大学医学部附属病院 小樽掖済会病院 市立豊中病院 静岡県立静岡がんセンター 東京大学医学部附属病院 福島県立医科大学附属病院 弘前大学医学部附属病院 今川内科医院 三豊総合病院 国立国際医療研究センター国府台病院 金沢大学附属病院 愛媛県立中央病院 大阪市立総合医療センター 国立病院機構函館病院 東北大学病院 福井県立病院 大阪市立大学医学部附属病院 石川県立中央病院 和歌山県立医科大学附属病院 大阪急性期・総合医療センター 虎の門病院 東京慈恵会医科大学附属病院 斗南病院

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 25 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study outline 1. Obtaining informed consent from the subjects. 2. The subjects answer Munich ChronoType Questionnaire. 3. Each investigator input the result of the questionnaire, endoscopic findings, and characteristics of the subjects into the case report form (CRF). 4. CRF of each institutions are sent to Yamaguchi University and analyzed.

Management information
Registered date	2018 Year 01 Month 23 Day
Last modified on	2018 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035355