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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034449
Receipt No. R000039281
Scientific Title Investigation of the upper-gastrointestinal lesions using endocytoscopy system
Date of disclosure of the study information 2018/10/11
Last modified on 2018/10/11

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Basic information
Public title Investigation of the upper-gastrointestinal lesions using endocytoscopy system
Acronym Endocytoscopy system for upper-gastrointestinal lesions
Scientific Title Investigation of the upper-gastrointestinal lesions using endocytoscopy system
Scientific Title:Acronym Endocytoscopy system for upper-gastrointestinal lesions
Region
Japan

Condition
Condition upper-gastrointestinal lesions
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We clarify the features of the surface cell morphology of both malignant and benign lesions of the upper-gastrointestinal tract using endocytoscopy system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accurate diagnosis rate concerning to the benign or malignant of the endocytoscopic pictures
Key secondary outcomes Accurate diagnosis rate concerning to the benign or malignant of the endocytoscopic pictures using AI.

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
15 years-old <
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients who agree to this study.
Key exclusion criteria Patients who have the history of side effect using dye for vital staining
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Youichi Kumagai
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Digestive tract and General Surgery
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, Japan
TEL 0492283619
Email kuma7srg1@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Youichi Kumagai
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Digestive tract and General Surgery
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, Japan
TEL 0492283619
Homepage URL
Email kuma7srg1@gmail.com

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2022 Year 04 Month 01 Day
Date of closure to data entry
2022 Year 04 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Endocytoscpe can clearly demonstrate the cells of esophagus, stomach, and duodenum. These pictures reflect the histopathological features.

Management information
Registered date
2018 Year 10 Month 11 Day
Last modified on
2018 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039281

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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