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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035386
Receipt No. R000040320
Scientific Title Prospective exploratory study about the laser endoscopy findings of duodenal epithelium in medical examinees
Date of disclosure of the study information 2019/01/11
Last modified on 2019/01/11

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Basic information
Public title Prospective exploratory study about the laser endoscopy findings of duodenal epithelium in medical examinees
Acronym LCI-D
Scientific Title Prospective exploratory study about the laser endoscopy findings of duodenal epithelium in medical examinees
Scientific Title:Acronym LCI-D
Region
Japan

Condition
Condition None
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the clinical features about the difference of the duodenal epithelium color by LCI (linked color imaging) about the medical examenees with gastroscopy
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The color of duodenal epithelium with LCI and the color difference of duodenal epithelium compared WLI (white light imaging) and LCI about medical examenees with gastroscopy
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 Medical examinees with gastroscopy at Ebisu Heart Building Clicnic
Key exclusion criteria 1) Examinees who has been performed the operation of upper gastrointestine
2) Examinees who has gastrointestinal heredital diseases including familial adenomatous polyposis and hereditary non-polyposis colorectal cancer
3) Examinees who has severe organ failure
4) Examinees who is considered ungrammatical by the endoscopists
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiko Kato
Organization Keio university, School of medicine
Division name Gastrointestinal medicine
Zip code
Address 35, Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3437
Email moto28hiko@icloud.com

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Nakayama
Organization Keio university, School of medicine
Division name Cancer center
Zip code
Address 35, Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3437
Homepage URL
Email anakayama34@keio.jp

Sponsor
Institute Keio university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 11 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
2018 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 12 Month 27 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040320

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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