UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030960 |
|---|---|
| Receipt number | 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 23:39:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
junnis@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
