UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009793 |
|---|---|
| Receipt number | R000011471 |
| Scientific Title | The mass of inflammatory cytokines are related to colon or rectum pre/post operation. Study of cytokine and postoperative complication. |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2019/08/27 20:28:23 |
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Basic information
Public title
The mass of inflammatory cytokines are related to colon or rectum pre/post operation. Study of cytokine and postoperative complication.
Acronym
The mass of inflammatory cytokines are related to colon or rectum pre/post operation. Study of cytokine and postoperative complication.
Scientific Title
The mass of inflammatory cytokines are related to colon or rectum pre/post operation. Study of cytokine and postoperative complication.
Scientific Title:Acronym
The mass of inflammatory cytokines are related to colon or rectum pre/post operation. Study of cytokine and postoperative complication.
Region
| Japan |
Condition
Condition
Colon cancer, colon/rectum perforation
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of cytokine and postoperative complication.
Prospect of prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mass of cytokine
Postoperative complication
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
| 16 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We can take a pre and postoperative blood test.
A case of colon or rectum operation.
Key exclusion criteria
No suit of above requirement.
A case of no agreement.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Sakamoto |
Organization
Juntendo University, faculty of medicine
Division name
Department of Coloproctological Surgery
Zip code
Address
2-1-1 Hongo Bunkyouku Toukyo Japan
TEL
03-3813-3111
kazusaka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Komiyama Hiromitsu |
Organization
Juntendo University, faculty of medicine
Division name
Department of Coloproctological Surgery
Zip code
Address
2-1-1 Hongo Bunkyouku Toukyo Japan
TEL
03-3813-3111
Homepage URL
netsurg2000@gmail.com
Sponsor or person
Institute
Juntendo University, faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2013 | Year | 02 | Month | 01 | 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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Colon and rectum perforation increase various inflammatory cytokine.
Management information
Registered date
| 2013 | Year | 01 | Month | 16 | Day |
Last modified on
| 2019 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011471
