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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008037
Receipt No. R000009465
Scientific Title New Classification for Hepatocellular Carcinoma by Computed Tomography
Date of disclosure of the study information 2012/05/28
Last modified on 2014/12/01

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Basic information
Public title New Classification for Hepatocellular Carcinoma by Computed Tomography
Acronym New Classification for HCC by CT
Scientific Title New Classification for Hepatocellular Carcinoma by Computed Tomography
Scientific Title:Acronym New Classification for HCC by CT
Region
Japan

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

Objectives
Narrative objectives1 To make a new classification for HCC using CT.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Establishment of a new classification.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent liver resection for HCC.
Key exclusion criteria Patients with iodine hypersensitivity
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Nakayama
Organization Nihon University School of Medicine
Division name Department of Digestive Surgery
Zip code
Address 30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan
TEL +81-3-3972-8111
Email nakayama.hisashi@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Nakayama
Organization Nihon University School of Medicine
Division name Department of Digestive Surgery
Zip code
Address 30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan
TEL +81-3-3972-8111
Homepage URL
Email nakayama.hisashi@nihon-u.ac.jp

Sponsor
Institute Department of Digestive Surgery, Nihon University School of Medicine
Institute
Department

Funding Source
Organization Nihon University Multidisciplinary Research Grant for 2011 and 2012
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
2012 Year 05 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Proposal of objective morphological classification system for hepatocellular carcinoma using preoperative multiphase computed tomography.
Nakayama H, Takayama T, Okubo T, Higaki T, Midorikawa Y, Moriguchi M, Itoh A.
J Gastroenterol. 2014 Oct;49(10):1430-7. doi: 10.1007/s00535-013-0908-9. Epub 2013 Nov 16.
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 Completed
Date of protocol fixation
2007 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 01 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 RESULTS:
Using a hierarchical cluster analysis, the shapes were classified into three groups: Type I (smooth: n = 158), Type II (jagged: n = 63), and Type III (rough: n = 11). The 5-year survival rates for Types I, II, and III were 64, 53, and 0 %, respectively (I vs. II, P = 0.038; I vs. III, P = 0.001; II vs. III, P = 0.002). The 5-year disease-free survival rates for Types I, II, and III were 27, 23, and 0 %, respectively (I vs. III, P = 0.0003 and II vs. III, P = 0.008). Microscopic portal venous invasion was significantly more likely with Type III than with Type I or II (P < 0.001 and P = 0.001, respectively).

CONCLUSIONS:
The newly developed semiautomatic computed tomography-based morphological classification system appears to provide a promising additional criterion for the prognostic categorization of patients with hepatocellular carcinoma.

Management information
Registered date
2012 Year 05 Month 28 Day
Last modified on
2014 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009465

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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