UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021465 |
|---|---|
| Receipt number | R000024757 |
| Scientific Title | The study of endoscopic image and histological evaluation using Linked Color Imaging regarding to gastric gastritis |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2018/03/16 12:18:46 |
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Basic information
Public title
The study of endoscopic image and histological evaluation using Linked Color Imaging regarding to gastric gastritis
Acronym
The study of endoscopic image and histological evaluation using Linked Color Imaging regarding to gastric gastritis
Scientific Title
The study of endoscopic image and histological evaluation using Linked Color Imaging regarding to gastric gastritis
Scientific Title:Acronym
The study of endoscopic image and histological evaluation using Linked Color Imaging regarding to gastric gastritis
Region
| Japan |
Condition
Condition
Atrophic gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To objectively assess whether Linked Color Imaging (LCI) is possible to provide clear and exact image to distinguish endoscopic mucosal atrophic border and to clarify what the color tone of LCI reflects histologically
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We quantify the colors of atrophic mucosa and non-atrophic mucosa in the region of endoscopic mucosal atrophic border and compare the colors between observations by normal light image and by LCI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
We will perform a biopsy on atrophic mucosa and non-atrophic mucosa in the region of endoscopic mucosal atrophic border. In addition, We will perform a biopsy on some characteristic gastric mucosal changes.
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. A case diagnosed atrophic gastritis by esophagogastroduodenography
Key exclusion criteria
1) A case who have diseases which cause a large impact on gastric mucosa such as liver cirrhosis or amyloidosis
2) A case who takes Non-steroidal anti-inflammatory drugs or steroid
3) A case who can't stop taking antithrombotic drug
4) a case to be judged unsuitable
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Mizukami |
Organization
Oita university
Division name
Department of Gastroenterology
Zip code
Address
1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Oita
TEL
097-586-6193
mizkaz0809@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Mizukami |
Organization
Oita university
Division name
Department of Gastroenterology
Zip code
Address
1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Oita
TEL
097-586-6193
Homepage URL
mizkaz0809@oita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Oita university
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Oita university
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
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
| 2016 | Year | 03 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 14 | Day |
Last modified on
| 2018 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024757
