UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008037 |
|---|---|
| Receipt number | 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 08:23:21 |
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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
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
nakayama.hisashi@nihon-u.ac.jp
Sponsor or person
Institute
Department of Digestive Surgery, Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009465
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