UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034449 |
|---|---|
| Receipt number | 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 | 2021/10/13 10:19:10 |
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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
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
kuma7srg1@gmail.com
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
| 2012 | Year | 04 | Month | 01 | Day |
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
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039281
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
