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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026380
Receipt No. R000030298
Scientific Title Monitoring kinetics of cytokines and growth factors before and after liver resection
Date of disclosure of the study information 2017/03/03
Last modified on 2017/03/07

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Basic information
Public title Monitoring kinetics of cytokines and growth factors before and after liver resection
Acronym Monitoring Kinetics of cytokines and growth factors before and after liver resection
Scientific Title Monitoring kinetics of cytokines and growth factors before and after liver resection
Scientific Title:Acronym Monitoring Kinetics of cytokines and growth factors before and after liver resection
Region
Japan

Condition
Condition Hepatocellular Carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Identify marker for Hepatocellular carcinoma recurrence after liver resection
Basic objectives2 Others
Basic objectives -Others Identify marker for early recurrence of Hepatocellular carcinoma after liver resection
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluating platelet-derived serotonin association with early (less than 2 years) and late (more than 2 years) Hepatocellular carcinoma recurrence after liver resection
Key secondary outcomes Vascular endothelial growth factor-A, TNF, IL-6, Hepatocyte growth factor, Angiopoietin 1 and 2, Epidermal growth factor, soluble Vascular endothelial growth factor receptor 1 and 2, Insulin-like growth factor 1 and 2, TGF beta, Angiotensin-(1-7), ACE and ACE2, Platelet derived growth factor-BB




Base
Study type Others,meta-analysis etc

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 Hepatocellular carcinoma patients
who undergoes liver resection
Key exclusion criteria Patients taking anti-platelet drugs,
platelet transfusion and psychosomatic medicines
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Imoto
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Cardiovascular and Gastroenterological surgery
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL 099-275-5368
Email imotom3@kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Shimizu
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Laboratory and Vascular Medicine
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan
TEL 099-275-5437
Homepage URL
Email tshimizu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Cardiovascular and Gastroenterological surgery, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Research expenses of Laboratory and Vascular Medicine, Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization Other
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
2017 Year 03 Month 03 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
2013 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 02 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 50 Hepatocellular carcinoma patients undergoing liver resection with informed consent to participate in the study is included. 50 healthy volunteers were also considered. Study period is from January 31, 2013 to January 31, 2018.
We evalute VEGF-A, TNF, IL-6, HGF, Ang-1 and -2, EGF, sVEGFR-1 and -2, IGF-1 and -2, TGF-beta, Angiotensin-(1-7), ACE and ACE2, and PDGF-BB in serum, plasma and intra-platelet.



Management information
Registered date
2017 Year 03 Month 03 Day
Last modified on
2017 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030298

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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