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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007146
Receipt No. R000008405
Scientific Title The diagnosis of malignacy and treatment protocolin hepatocellular carcinoma ; The establish of method by 18F-fluorodeoxyglucose-positron emission tomography-computed tomography
Date of disclosure of the study information 2012/01/27
Last modified on 2012/01/26

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Basic information
Public title The diagnosis of malignacy and treatment protocolin hepatocellular carcinoma ; The establish of method by 18F-fluorodeoxyglucose-positron emission tomography-computed tomography
Acronym The diagnosis of malignacy and treatment protocolin HCC ; The establish of method by 18F-FDG-PET/CT
Scientific Title The diagnosis of malignacy and treatment protocolin hepatocellular carcinoma ; The establish of method by 18F-fluorodeoxyglucose-positron emission tomography-computed tomography
Scientific Title:Acronym The diagnosis of malignacy and treatment protocolin HCC ; The establish of method by 18F-FDG-PET/CT
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of study was to investigate the accuracy of diagnosis intrahepatic metastasis and microvascular invasion in HCC by standardized uptake value and to analyze postoperative recurrence rate in patients of HCC after radical operation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The purpose of study was to measure standardized uptake value in HCC with intrahepatic metastasis and microvascular invasion and to measure the each survival rate after treatment and each event-free survival rate in HCC of high and low standardized uptake value.
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 1)Patients with HCC.
2)Patients whose liver damage score is A or B.
3)Patients who could be examined with FDG-PET/CT.
4)Written agreement of participation for this study could be obtained
Key exclusion criteria 1)Written agreement of participation for this study could not be obtained.
2)Patients who could not be examined with FDG-PET/CT.
3)Patients whose fasting blood glucose is more than 200 mg/dl
4)Patients whose liver damage score is C.
5)Patients whose Indocyanine green retention rate at 15 min (ICGR15) is more than 40%
6)Patients who were estimated that it is inappropriate to participate the study by the responsible physician.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Hiasa
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL +81-89-960-5308
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hironori Ochi
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL +81-89-960-5308
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
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
2012 Year 01 Month 27 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 Open public recruiting
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 07 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 The patients who participate in this study will be received blood biochemical examination and imaging examination, including FDG-PET/CT before therapy.
Compared pathological findings with the results of preoperative examination, we examine which examination is useful for prediction microsatellite lesion. We examine whether pet is useful for predicting the postoperative prognosis.

Management information
Registered date
2012 Year 01 Month 26 Day
Last modified on
2012 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008405

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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