UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031260 |
|---|---|
| Receipt number | R000035678 |
| Scientific Title | Clinical characteristics of Helicobacter pylori naive non-cardiac gastric adenocarcinoma |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/02/13 00:02:33 |
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Basic information
Public title
Clinical characteristics of Helicobacter pylori naive non-cardiac gastric adenocarcinoma
Acronym
Clinical characteristics of Helicobacter pylori naive non-cardiac gastric adenocarcinoma
Scientific Title
Clinical characteristics of Helicobacter pylori naive non-cardiac gastric adenocarcinoma
Scientific Title:Acronym
Clinical characteristics of Helicobacter pylori naive non-cardiac gastric adenocarcinoma
Region
| Japan |
Condition
Condition
Early gastric adenocarcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate clinical characteristics of adenocarcinoma in H. pylori naive patients
Basic objectives2
Others
Basic objectives -Others
Retrospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate clinical characteristics of adenocarcinoma in H. pylori naive patients
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
Patients who received treatment for gastric neoplasia between January 2010 and May 2016
Key exclusion criteria
The cases of cardiac cancer, remnant gastric cancer and familial adenomatous polyposis (FAP)
Target sample size
1430
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriya Uedo |
Organization
Osaka International Cancer Institute
Division name
Gastrointestinal Oncology
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
uedou-no@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriya Uedo |
Organization
Osaka International Cancer Institute
Division name
Gastrointestinal Oncology
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
Homepage URL
uedou-no@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Institute
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
大阪国際がんセンター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | 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
The prevalence of H. pylori naive gastric adenocarcinoma among early gastric adenocarcinoma patients was 1.26%.
H. pylori naive early gastric adenocarcinoma
were more frequent in young patients, more likely to be undifferentiated type, and more frequently in the upper third of the stomach.
Especially, in differentiated type, tumor location was predominant in the upper third, while others were in the lower third
In differentiated type, gastric mucin phenotype was more common.
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
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | 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
The survey variables described in Study variables will be entered into Excel worksheets.We investigated difference of clinical characteristics between H. pylori-naive and -infected adenocarcinoma; age, sex, tumor location, size, macroscopic type and histological findings, and clinical outcome.
Difference of mucin phenotype were diagnosed
according to MUC5AC, MUC6, CD10 and MUC2 staining.
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035678
