UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002902 |
|---|---|
| Receipt number | 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 19:35:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003539
