UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021182 |
|---|---|
| Receipt number | R000024425 |
| Scientific Title | Multi-institutional study of immunologic response tu surgical stress in patients undergoing pulmonary lobectomy |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2018/08/29 18:26:10 |
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Basic information
Public title
Multi-institutional study of immunologic response tu surgical stress in patients undergoing pulmonary lobectomy
Acronym
Immunologic response to surgical stress of lobectomy
Scientific Title
Multi-institutional study of immunologic response tu surgical stress in patients undergoing pulmonary lobectomy
Scientific Title:Acronym
Immunologic response to surgical stress of lobectomy
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate an immunologic response according to trauma size paitents undergoing pulmonary lobectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between trauma size and short-term outcome including immunologic response and morbidity
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Need for lobectomy
That consent is obtained
Key exclusion criteria
The person in charge ise determined to be inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Risa Oda |
Organization
Nagoya City University
Division name
Department of Oncology,Immunology and Surgery
Zip code
Address
1 kawasumi,mizuho-cho,mizuho-ku,Nagoya,Aichi,Japan
TEL
052-853-8231
pear_pear111@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Risa Oda |
Organization
Nagoya City University
Division name
Department of Oncology,Immunology and Surgery
Zip code
Address
1 kawasumi,mizuho-cho,mizuho-ku,Nagoya,Aichi,Japan
TEL
052-853-8231
Homepage URL
pear_pear111@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
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
| 2016 | Year | 02 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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
object:patiants who underwent lobectomy for clinical stage 1A lung cancer.
measurement item:IL-4,6,8,10,Hb,WBC,Plt,CRP etc.
Management information
Registered date
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2018 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024425
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
