UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study to investigate clnicopathological characteristics of superficial esophagogastro junction cancer
Title of the study (Brief title)	EGJ_CA_Study
Region	Japan

Condition
Condition	Esophagogastro junction cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify clinicaopthological characteristics of superficial esophagogastro junction cancer
Basic objectives2	Others
Basic objectives -Others	Biocharacteristics
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Difference of clinicaopthological characteristics of superficial esophagogastro junction cancer according to presence and absence of endoscopic gastric corpus mucosal atrophy
Key secondary outcomes	1) Factors associated with endoscopic gastric corpus mucosal atrophy 2) Difference of clinicaopthological characteristics of superficial esophagogastro junction cancer according to presence and absence of Barrett mucosa 3) Difference of clinicaopthological characteristics between EGJ cancer and Barrett cancer 4) Difference of clinicaopthological characteristics between EGJ cancer and gastric cancer in the upper body.

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	1) Siewert type 2 cancer (true cardia cancer: adenocarcinoma located within 1 cm above and 2 cm below the GE Junction) 2) pathological T1
Key exclusion criteria	1) Unevaluable endoscopic images 2) Unevaluable histological findings
Target sample size	200

Research contact person
Name of lead principal investigator	Noiya Uedo
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Address	3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
TEL	06-6972-1181
Email	uedou-no@mc.pref.osaka.jp

Public contact
Name of contact person	Kazuhiro Katayama
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Address	3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
TEL	06-6972-1181
Homepage URL
Email	kbyori01@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 08 Day
Anticipated trial start date	2016 Year 10 Month 25 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	Published
URL releasing results
Results
Other related information	Study design is a retrospective cross-sectional study. Patients' data who treated in following Japanese institutions during 2010-2015 and met inclusion criteria were retrieved: 1) Cancer Institute Hospital of Japanese Foundation for Cancer Research, 2) Keio University Hospital, 3) Nagaoka Red Cross Hospital, 4) National Cancer Center Central Hospital, 5) National Cancer Center Hospital East, 6) Osaka Medical Center for Cancer and Cardiovascular Diseases, 7) Teine Keijinkai Hospital, 8) Tohoku University Hospital

Management information
Registered date	2016 Year 12 Month 18 Day
Last modified on	2017 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028344