UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021199 |
|---|---|
| Receipt number | R000024440 |
| Scientific Title | Examination of differences of color between intestinal metaplasia and background mucosa using Linked Color Imaging (LCI) |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2018/08/30 09:23:52 |
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Basic information
Public title
Examination of differences of color
between intestinal metaplasia and background mucosa using Linked Color Imaging (LCI)
Acronym
Diagnosis of intestinal metaplasia using LCI
Scientific Title
Examination of differences of color
between intestinal metaplasia and background mucosa using Linked Color Imaging (LCI)
Scientific Title:Acronym
Diagnosis of intestinal metaplasia using LCI
Region
| Japan |
Condition
Condition
Helicobacter pylori-induced gastritis
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the differences of color between the gastric mucosa with or without intestinal metaplasia using LCI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences of color between white-light imaging and LCI in the lesions with or without intestinal metaplasia.
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
The patients who hope endoscopic diagnosis of H. pylori-induced gastritis including gastric biopsy in Hokkaido University Hospital are included.
1. the patients who are 20 years or older at the agreement acquisition
2. the patients receive endoscopy using LCI
Key exclusion criteria
The patients who can not receive biopsy for background disease or use of antithrombotic drugs
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoko Ono |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
Nishi-5, Kita-14, Kita-ku, Sapporo 060-8638, Japan
TEL
0117161161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoko Ono |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
Nishi-5, Kita-14, Kita-ku, Sapporo 060-8638, Japan
TEL
0117161161
Homepage URL
onosho@med.hokudai.ac.jp
Sponsor or person
Institute
Division of Endoscopy, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Endoscopy, Hokkaido University Hospital
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study using gastric biopsy specimen.
The patients who receive upper endoscopy including H. pylori infection status.
Cross sectional method, all the patients who meet our criteria between March 2016 and August 2017.
Measurement:endoscopic images(white light and LCI), H. pylori tests, biopsies.
Management information
Registered date
| 2016 | Year | 02 | Month | 25 | Day |
Last modified on
| 2018 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024440
| Research Plan | |
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| 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 |
