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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
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 | 2020/01/09 |
Basic information | ||
Public title | Sonazoid Enhanced LivEr Cancer
Trial for Early Detection |
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Acronym | SELECTED Study | |
Scientific Title | Sonazoid Enhanced LivEr Cancer
Trial for Early Detection |
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Scientific Title:Acronym | SELECTED Study | |
Region |
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Condition | ||
Condition | Hepatitis B virus or Hepatitis C virus related liver cirrhosis | |
Classification by specialty |
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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 |
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Interventions/Control_1 | <Group of CE-US>
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months |
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Interventions/Control_2 | <Group of B-mode US>
screening by conventional B-mode US every 3-5 months |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 760 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Baseline Characteristics | |||||||
Participant flow | |||||||
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Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |