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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002238
Receipt No. R000002735
Scientific Title An evaluation by the measurement of the inflammatory reaction of the gastric cancer postoperative drain fluid
Date of disclosure of the study information 2009/07/23
Last modified on 2009/07/22

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Basic information
Public title An evaluation by the measurement of the inflammatory reaction of the gastric cancer postoperative drain fluid
Acronym A gastric cancer postoperative level of inflammatory evaluation
Scientific Title An evaluation by the measurement of the inflammatory reaction of the gastric cancer postoperative drain fluid
Scientific Title:Acronym A gastric cancer postoperative level of inflammatory evaluation
Region
Japan

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

Objectives
Narrative objectives1 We evaluate the differences in the peritoneal immune response by evaluation of cytokine collected from the peritoneal drain fluid after LADG and ODG.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We evaluate the differences in the peritoneal immune response by evaluation of cytokine collected from the peritoneal drain fluid after LADG and ODG. The cytokine levels of drain fluid are estimated both ODG group and LADG group using nonparametric test.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.A curative resection case
2.It doesn't matter about age, sex, the presence or absence of previous treatment (but excluded in the immunosuppressive condition)
3.Written informed consent
4.Inpatients
Key exclusion criteria 1.Non curative resection case
2.Immunosuppressive condition
3.Disqualified by attending doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba University Graduate School of Medicine
Division name Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chuouku,Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Natsume
Organization Chiba University Graduate School of Medicine
Division name Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chuouku,Chiba
TEL 043-222-7171
Homepage URL
Email

Sponsor
Institute Chiba 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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 23 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
Date of protocol fixation
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To compare objectively the differences in the peritoneal immune response collected from the peritoneal drain fluid after LADG and ODG


Management information
Registered date
2009 Year 07 Month 22 Day
Last modified on
2009 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002735

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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