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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022898
Receipt No. R000026388
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
Date of disclosure of the study information 2016/06/28
Last modified on 2021/06/30

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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