UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Monitoring kinetics of cytokines and growth factors before and after liver resection
Title of the study (Brief title)	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	Yutaka Imoto
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Cardiovascular and Gastroenterological surgery
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	Toshiaki Shimizu
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Laboratory and Vascular Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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