UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications	https://www.karger.com/Article/FullText/501082
Number of participants that the trial has enrolled	656
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 06 Month 06 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 10 Month 10 Day
Date of IRB	2008 Year 11 Month 17 Day
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	2020 Year 01 Month 09 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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