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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000970
Receipt No. 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

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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
Institute Department of Internal Medicine, National Hospital Organization IwakuniClinical Center
Institute
Department

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
URL(English) https://upload.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


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