UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024282 |
|---|---|
| Receipt number | R000027976 |
| Scientific Title | Investigation of Micro-mucosal Pattern of Gastric Antrum using Magnifying Narrow Band Imaging in Patients with Chronic Atrophic Fundic Gastritis |
| Date of disclosure of the study information | 2016/10/04 |
| Last modified on | 2016/10/04 15:08:46 |
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Basic information
Public title
Investigation of Micro-mucosal Pattern of Gastric Antrum using Magnifying Narrow Band Imaging in Patients with Chronic Atrophic Fundic Gastritis
Acronym
Investigation of Micro-mucosal Pattern of Gastric Antrum using NBI
Scientific Title
Investigation of Micro-mucosal Pattern of Gastric Antrum using Magnifying Narrow Band Imaging in Patients with Chronic Atrophic Fundic Gastritis
Scientific Title:Acronym
Investigation of Micro-mucosal Pattern of Gastric Antrum using NBI
Region
| Japan |
Condition
Condition
Atrophic gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the distribution and histology of micro-mucosal pattern in the antrum based on magnifying endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association among the extent of CAFG, the micro-mucosal pattern, and histology
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Early stage noncardiac gastric cancer who presented to our institution to receive endoscopic submucosal dissection.
Key exclusion criteria
History of H.pylori eradication
Gastric resection
Severe organ failure
Anticoagulant or nonsteroidal anti-inflammatory medication within 7 days of this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uedo Noriya |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan.
TEL
06-6972-1181
uedou-no@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamasaki Yasushi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan.
TEL
06-6972-1181
Homepage URL
yamazaki-ya@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
N/A
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 | 10 | Month | 04 | 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
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 04 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 04 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 04 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2016 | Year | 10 | Month | 04 | Day |
Last modified on
| 2016 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027976
