UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000970
Receipt number R000001129
Scientific Title Analysis of risk factors and prognostic factors included histological status of underlying liver disease of patients undergoing curative resection or radiofrequency ablation of hepatocellular carcinoma; May hepatic steatosis correlate with the postoperative recurrence of hepatocellular carcinoma?
Date of disclosure of the study information 2008/02/01
Last modified on 2014/07/06 21:18:36

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Basic information

Public title

Analysis of risk factors and prognostic factors included histological status of underlying liver disease of patients undergoing curative resection or radiofrequency ablation of hepatocellular carcinoma; May hepatic steatosis correlate with the postoperative recurrence of hepatocellular carcinoma?

Acronym

Risk and Prognostic factors included hepatic steatosis of HCC

Scientific Title

Analysis of risk factors and prognostic factors included histological status of underlying liver disease of patients undergoing curative resection or radiofrequency ablation of hepatocellular carcinoma; May hepatic steatosis correlate with the postoperative recurrence of hepatocellular carcinoma?

Scientific Title:Acronym

Risk and Prognostic factors included hepatic steatosis of HCC

Region

Japan


Condition

Condition

Patients with Hepatocellular carcinoma(HCC) after curative treatment

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Recently, a correlation between liver steatosis and HCC was reported except for liver fibrosis and inflammation . Moreover,
HCC from NASH(nonalcholic steatohepatitis) seems to increases, and we mainly and prospectively observe the correlation between the risk factors of recurrence of HCC, and these histological findings such as liver steatosis, liver fibrosis, and inflammation after curative treatments of HCC.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The cumulative tumor recurrence rate in patients with HCC

Key secondary outcomes

Cumulative survival rate in patients with HCC.
Risk factors of recurrence of HCC and prognostic factors(these histological findings such as liver steatosis, liver fibrosis, and inflammation, Cancer Stage, Child-Pugh,and laboratory data, etc.)


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

a)HCC without prior treatments
b)Patients underwent curative resection or radiofrequency ablation therapy(RFA) of HCC. Resection was defined as curative when the entire tumor was macroscopically removed and the surgical margin was microscopically free from tumor invasion.
c)For patients with HCC the Milan criteria were applied (solitary tumor of 5 cm, or three or fewer lesions, none >3 cm without vascular invasion, or extrahepatic metastasis).

Key exclusion criteria

a)Recurred HCC
b)uncontrolled other malignancies
c)ruptured HCC
d)Operation-related death
e)Judged to be inadequate case of this clinical study for other reasons by doctors

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Takuma

Organization

National Hospital Organization Iwakuni
Clinical Center

Division name

Internal Medicine

Zip code


Address

2-5-1 Kuroiso-cho, Iwakuni, Yamaguchi, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

National Hospital Organization IwakuniClinical Center

Division name

Internal Medicine

Zip code


Address


TEL


Homepage URL


Email

takuma@iwakuni-nh.go.jp


Sponsor or person

Institute

Department of Internal Medicine, National Hospital Organization IwakuniClinical Center

Institute

Department

Personal name



Funding Source

Organization

None

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


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

2008 Year 02 Month 01 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

Terminated

Date of protocol fixation

2004 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2004 Year 07 Month 01 Day

Last follow-up date

2015 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We mainly and prospectively observe the correlation between the risk factors of recurrence of HCC, and these histological findings such as liver steatosis, liver fibrosis, and inflammation after curative treatments of HCC.
The criteria established by Desmet et al. as follows: F0 (no fibrosis), F1 (mild fibrosis), F2 (moderate fibrosis), and F3 (severe fibrosis) are categorized noncirrhosis; and F4 (cirrhosis) is categorized cirrhosis. The degree of necroinflammatory activity is scored as A0 (no activity) A1 (mild activity), A2 (moderate activity), and A3 (severe activity). The severity of steatosis is graded by Brunt et al.
NASH(nonalcholic steatohepatitis) is diagnosed according to Matteoni et al.
Accordingly, the patients with NAFLD(nonalcoholic fatty liver desease) type 3 and type 4 are assigned to NASH.


Management information

Registered date

2008 Year 01 Month 06 Day

Last modified on

2014 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001129


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name