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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030960
Receipt No. R000035355
Scientific Title Exploring the association between upper gastrointestinal disease and chronotype: a multicenter study in Japan
Date of disclosure of the study information 2018/01/25
Last modified on 2018/01/23

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Basic information
Public title Exploring the association between upper gastrointestinal disease and chronotype: a multicenter study in Japan
Acronym Association between upper gastrointestinal disease and chronotype
Scientific Title Exploring the association between upper gastrointestinal disease and chronotype: a multicenter study in Japan
Scientific Title:Acronym 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
1st name
Middle name
Last name Jun Nishikawa
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Laboratory Science
Zip code
Address Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL 0836-22-2835
Email junnis@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Nishikawa
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Laboratory Science
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 10 Month 01 Day
Date of IRB
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

Other
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

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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