UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001612 |
|---|---|
| Receipt number | R000001939 |
| Scientific Title | Sonazoid Enhanced LivEr Cancer Trial for Early Detection |
| Date of disclosure of the study information | 2009/01/01 |
| Last modified on | 2020/01/09 10:44:39 |
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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
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
kaz-ues@med.kindai.ac.jp
Sponsor or person
Institute
Japan Liver Oncology Group (JLOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001939
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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