UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026380
Receipt number 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 10:49:32

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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