UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002238 |
|---|---|
| Receipt number | 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 23:18:55 |
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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
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
Sponsor or person
Institute
Chiba 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002735
