UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019145 |
|---|---|
| Receipt number | R000022135 |
| Scientific Title | The chronological analysis of platelet proteins and peptides in pre- and post-operative condition. |
| Date of disclosure of the study information | 2015/09/29 |
| Last modified on | 2018/12/17 15:33:03 |
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Basic information
Public title
The chronological analysis of platelet proteins and peptides in pre- and post-operative condition.
Acronym
The chronological analysis of platelet proteins and peptides in pre- and post-operative condition.
Scientific Title
The chronological analysis of platelet proteins and peptides in pre- and post-operative condition.
Scientific Title:Acronym
The chronological analysis of platelet proteins and peptides in pre- and post-operative condition.
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We analyze the chronological change of platelet protein and peptide before and after partial hepatectomey.
Basic objectives2
Others
Basic objectives -Others
We identify the specific growth factors or cytokines produced by platelet during liver regeneration.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intra-platelet vascular endothelial growth factor (VEGF) and Angiopoietin-1.
Serum and plasma; Hepatocyte growth factor(HGF), Epithelial cell growth factor (EGF), soluble VEGF receptor (sVEGFR-1,2), von Willebrand factor (vWF), platelet derived growth factor-BB (PDGF-BB)
Key secondary outcomes
Tumor necrosis factor alpha (TNFalpha), Interleukine-6 (IL-6)
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
Patients with hepatocellular carcinoma scheduled to recieve partial hepatectomy.
Key exclusion criteria
N/A
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Imoto |
Organization
Kagoshima Unviersity Graduate School of Medical and Dental Sciences
Division name
Cardiovascular and Gastroenterological Surgery
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-5368
imoto@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Kadono |
Organization
Kagoshima Unviersity Graduate School of Medical and Dental Sciences
Division name
Cardiovascular and Gastroenterological Surgery
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-5368
Homepage URL
http://com4.kufm.kagoshima-u.ac.jp/information/department/015.html
kadono@m2.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima Unviersity Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular and Gastroenterological Surgery
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kirishima Medical Center
Kagoshima Medical Center
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
鹿児島大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | 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
Since we began this study on 2013 May, thirty seven patients were registered and analyzed.
Management information
Registered date
| 2015 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022135
| 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 |
