UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of image enhanced endoscopy in diagnosis of the disease range of gastric cancer with undifferentiated adenocarnimoma
Title of the study (Brief title)	Diagnosis of the disease range of gastric cancer with undifferentiated adenocarnimoma
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Examination of compatibility of disease range of gastric cancer with undifferentiated adenocarcinoma in endscopic diagnosis and pathological diagnoses
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Compatibility of disease range of gastric cancer with undifferentiated adenocarcinoma in endscopic diagnosis and pathological diagnoses
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Endoscopy
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	Undifferentiated early gastric cancer those will be underwent endoscopic therapy or surgery
Key exclusion criteria	Patients with pacemaker inserted in Patients diagnosed being with organic brain damage, depression or schizophrenia Patients who doctor is inappropriate
Target sample size	50

Research contact person
Name of lead principal investigator	Tai Omori
Organization	Keio University school of medicine
Division name	Cancer Center
Address	Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Email	t-omori@a3.keio.jp

Public contact
Name of contact person	Rieko Nakamura
Organization	Keio University school of medicine
Division name	Cancer Center
Address	Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	rieko-na@cam.hi-ho.ne.jp

Sponsor
Institute	Keio University
Institute
Department

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)

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	2014 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 17 Day
Anticipated trial start date	2012 Year 08 Month 17 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
Other related information

Management information
Registered date	2014 Year 06 Month 05 Day
Last modified on	2018 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010429