UMIN-CTR Clinical Trial

Basic information
Public title	Selection of high risk group of gastric cancer development in patients eradicated Helicobacter pylori using expression level of gastric mucosal PSCA/CD44v9: Retrospective multi-center trial
Acronym	Selection of high risk group of gastric cancer development
Scientific Title	Selection of high risk group of gastric cancer development in patients eradicated Helicobacter pylori using expression level of gastric mucosal PSCA/CD44v9: Retrospective multi-center trial
Scientific Title:Acronym	Selection of high risk group of gastric cancer development
Region	Japan

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

Objectives
Narrative objectives1	To clarify efficacy of grading system depended on gastric mucosal expression level of PSCA/CD44v9 in early-stage gastric cancer patients eradicated with H. pylori infection
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Observation period from endoscopic resection early stage gastric cancer to development of metachronous gastric cancer in early-stage gastric cancer patients eradicated with H. pylori infection
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	1. Early stage gastric cancer patients treated with endoscopic resection from Apr 2006 to Mar 2016 and were followed. 2. To check H. pylori infection by urea breath test, rapid urease test, culture or/and IgG. 3. With gastric cancer or adenoma pathologically 4. To be stocked resected gastric cancer. 5. With informed consent to enroll in this study
Key exclusion criteria	1. Patients who cannot check metachronou gastric cancer routinely. 2. patients received chemotherapy 3. with mental disorder
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Mitsushige Middle name Last name Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Zip code	5202192
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	077-548-2618
Email	sugimo@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Mitsushige Middle name Last name Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Zip code	5202192
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	077-548-2618
Homepage URL
Email	sugimo@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science Hospital
Institute
Department

Funding Source
Organization	Shiga University of Medical Science Hospital Division of Gastroenterology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiga University of Medical Science Hospital
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel	077-548-2217
Email	hqrec@belle.shiga-med.ac.jp

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 06 Month 28 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	15
Results
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 06 Month 03 Day
Date of IRB	2015 Year 06 Month 03 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Non

Management information
Registered date	2016 Year 06 Month 27 Day
Last modified on	2021 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026388