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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001612
Receipt No. R000001939
Scientific Title Sonazoid Enhanced LivEr Cancer Trial for Early Detection
Date of disclosure of the study information 2009/01/01
Last modified on 2012/01/23

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Basic information
Public title Sonazoid Enhanced LivEr Cancer
Trial for Early Detection
Acronym SELECTED Study
Scientific Title Sonazoid Enhanced LivEr Cancer
Trial for Early Detection
Scientific Title:Acronym SELECTED Study
Region
Japan

Condition
Condition Hepatitis B virus or Hepatitis C virus related liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis.
Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Size of HCC which is detected first
Key secondary outcomes 1) Time to detection of HCC
2) Number of HCC which is detected first
3) Stage of HCC which is detected first
4) The ability of definitive diagnosis of HCC
5) Sensitivity, Specificity and accuracy of the diagnosis of HCC
6) The improvement of prognosis of patients who are diagnosed in this study
7) The accumulated rate of detection of HCC

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine Maneuver
Interventions/Control_1 <Group of CE-US>
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
Interventions/Control_2 <Group of B-mode US>
screening by conventional B-mode US every 3-5 months
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 1) Age over 20
2) HBV or HCV related liver cirrhosis
3) No history of HCC
4) Diagnosed as liver cirrhosis histologically or clinically
Histologically confirmed by liver biopsy
Confirmed by formula of diagnosing cirrhosis
Radiological finding
Finding of portal hypertension
Platelet<130,000
5) Inpatient or outpatient
6) Patients who signed a written informed consent form
Key exclusion criteria 1) History of hypersensitivity to egg yolk
2) Pregnant or lactating women and women who may be pregnant
3) Severe liver dysfunction(AST, ALT,or BIL level >10ULN
4) Associated with HCC
5) Paients receiving interferon
6) Age under 20
7) Judged by investigator not to be appropriate for inclusion in this study
Target sample size 760

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Kudo
Organization Kinki University School of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 377-2, Oono-Higashi, Osaka-Sayama, Osaka, Japan
TEL 072-366-0221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuomi Ueshima
Organization Kinki University School of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 377-2, Oono-Higashi, Osaka-Sayama, Osaka, Japan
TEL 072-366-0221
Homepage URL
Email kaz-ues@med.kindai.ac.jp

Sponsor
Institute Japan Liver Oncology Group (JLOG)
Institute
Department

Funding Source
Organization Japan Liver Oncology Group (JLOG)
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 01 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 No longer recruiting
Date of protocol fixation
2008 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2019 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 01 Month 01 Day
Last modified on
2012 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001939

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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