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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002902
Receipt No. R000003539
Scientific Title Mapping Analysis of Ghrelin-Producing Cells in Human Stomach; the Relationship among Ghrelin Levels, H.pylori, Chronic Gastritis and Gastric Cancer
Date of disclosure of the study information 2009/12/15
Last modified on 2009/12/15

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Basic information
Public title Mapping Analysis of Ghrelin-Producing Cells in Human Stomach; the Relationship among Ghrelin Levels, H.pylori, Chronic Gastritis and Gastric Cancer
Acronym Mapping Analysis of Ghrelin-Producing Cells in Human Stomach
Scientific Title Mapping Analysis of Ghrelin-Producing Cells in Human Stomach; the Relationship among Ghrelin Levels, H.pylori, Chronic Gastritis and Gastric Cancer
Scientific Title:Acronym Mapping Analysis of Ghrelin-Producing Cells in Human Stomach
Region
Japan

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

Objectives
Narrative objectives1 We investigated the detailed distribution of ghrelin producing cells in tumor-free half of the human stomach by mapping analysis.
Basic objectives2 Others
Basic objectives -Others Distribution of the endocrine hormone
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the detailed distribution of ghrelin producing cells in tumor-free half of the human stomach by mapping analysis.
Key secondary outcomes circulating ghrelin levels, H.pylori infection, chronic gastritis, and differentiation of gastric cancer.

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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) the patients with gastric cancer who undergone total gastrectomy, 2) not recieved neoadjuvant therapy (chomotherapy, radiotherapy etc.), 3) obtained informed written consent.
Key exclusion criteria 1) age<20 or >90 year, 2) pregnancy, 3) diabetes mellitus, 4) systemic infection, 5) thyroid and liver disease, 6) renal dysfunction, and 7) administration of neoadjuvant chemotherapy.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Takiguchi
Organization Osaka University, Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2 Suita City Yamadaoka, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Adachi
Organization Osaka University, Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 15 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
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
2007 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective
case-control sampling

Management information
Registered date
2009 Year 12 Month 15 Day
Last modified on
2009 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003539

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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