UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Title of the study (Brief title)	The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate risk factors and appropriate follow-up period for metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess risk factors for metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Key secondary outcomes	To assess the time of onset of metachronous gastric cancer after endoscopic treatment for early gastric cancer.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	The relationship of degree of gastric mucosal atrophy on metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Interventions/Control_2	The relationship between successful H.pylori eradication arm and unsuccessful H.pylori eradication arm on metachronous gastric cancer after endoscopic treatment for early gastric cancer.
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 after endoscopic treatment for early gastric cancer
Key exclusion criteria	Patients after gastrectomy Patinets without curative resection of gastric cancer endoscopically
Target sample size	300

Research contact person
Name of lead principal investigator	Nonaka Takashi
Organization	Yokohama City University Hospital
Division name	Gastroenterology Division
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2640
Email	nonaka_taka@yahoo.co.jp

Public contact
Name of contact person	Nonaka Takashi
Organization	Yokohama City University Hospital
Division name	Gastroenterology Division
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2640
Homepage URL
Email	nonaka_taka@yahoo.co.jp

Sponsor
Institute	Gastroenterology Division, Yokohama City University Hospital
Institute
Department

Funding Source
Organization	none
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	2013 Year 01 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 01 Month 10 Day
Anticipated trial start date	2013 Year 01 Month 10 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	2012 Year 11 Month 19 Day
Last modified on	2016 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010999