UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical characteristics of Helicobacter pylori naive non-cardiac gastric adenocarcinoma
Title of the study (Brief title)	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	Noriya Uedo
Organization	Osaka International Cancer Institute
Division name	Gastrointestinal Oncology
Address	3-1-69, Otemae, Chuo-ku, Osaka
TEL	06-6945-1181
Email	uedou-no@mc.pref.osaka.jp

Public contact
Name of contact person	Noriya Uedo
Organization	Osaka International Cancer Institute
Division name	Gastrointestinal Oncology
Address	3-1-69, Otemae, Chuo-ku, Osaka
TEL	06-6945-1181
Homepage URL
Email	uedou-no@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035678