UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019392 |
|---|---|
| Receipt number | R000022432 |
| Scientific Title | Difference of Image Enhanced Endoscopic Findings Between Autoimmune and Helicobacter pylori associated Gastritis |
| Date of disclosure of the study information | 2015/10/18 |
| Last modified on | 2015/10/19 12:35:31 |
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Basic information
Public title
Difference of Image Enhanced Endoscopic Findings Between Autoimmune and Helicobacter pylori associated Gastritis
Acronym
HpAG GASTRITIS STUDY
Scientific Title
Difference of Image Enhanced Endoscopic Findings Between Autoimmune and Helicobacter pylori associated Gastritis
Scientific Title:Acronym
HpAG GASTRITIS STUDY
Region
| Japan | Europe |
Condition
Condition
Chronic atrophic gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate difference of image enhanced endoscopic and histological findings between autoimmune and H. pylori associated gastritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Micromucosal structure observed by magnifying NBI images
Key secondary outcomes
Extent of atrophic gastritis observed by autofluorescence images, Histology of biopsy specimen
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with H. pylori associated gastritis, autoimmune gastritis, and H. pylori negative normal patients
1) Patients presented with mild or no symptom for receiving EGD
2) Patients with history of endoscopic treatment or concomitant early stage gastric cancer or carcinoid
3) Provision of written informed consent
Key exclusion criteria
1) History of gastrectomy
2) previously received eradication therapy for H. pylori infection
3) Taking anticoagulant medication or nonsteroidal anti-inflammatory drugs (NSAIDs) within 30 days
4) Hemorrhagic diseases
5) Uncontrolled type 1 diabetes mellitus
6) Cirrhosis
7) Renal failure
8) Pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriya Uedo |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
TEL
06-6972-1181
uedou-no@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriya Uedo |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
TEL
06-6972-1181
Homepage URL
uedou-no@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 10 | Month | 18 | 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
Micromucosal pattern of the corpus mucosa in patients with H. pylori associated gastritis is likely to show Groove type that mimic the antral or intestinal mucosa, while that of autoimmune gastritis was Foveola type suggesting different pathogenesis of these diseases.
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
| 2014 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Case control study
Recruitment: Patients undergone esophagogastroduodenoscopy in our endoscopy unit and given written informed consent to participate in this study.
Measured outcome: Extent of atrophic gastritis in autofluorescence imaging, micromucosal pattern in magnifying NBI images, and histology of biopsy specimens.
Management information
Registered date
| 2015 | Year | 10 | Month | 18 | Day |
Last modified on
| 2015 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022432
