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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039467
Receipt No. R000044956
Scientific Title Usefulness of laminin gamma 2 (LG2m) as predictive factor for the development of hepatocellular carcinoma
Date of disclosure of the study information 2020/02/12
Last modified on 2020/02/12

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Basic information
Public title Usefulness of laminin gamma 2 (LG2m) as predictive factor for the development of hepatocellular carcinoma
Acronym Usefulness of laminin gamma 2 (LG2m) as predictive factor for the development of hepatocellular carcinoma
Scientific Title Usefulness of laminin gamma 2 (LG2m) as predictive factor for the development of hepatocellular carcinoma
Scientific Title:Acronym Usefulness of laminin gamma 2 (LG2m) as predictive factor for the development of hepatocellular carcinoma
Region
Japan

Condition
Condition Patients with risk factors for hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of Laminin2 as predictive factor for the development of hepatocellular carcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of hepatocellular carcinoma
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients
Cohort 1: previously diagnosed as chronic hepatitis C and achieved sustained virological responses
Cohort 1: currently diagnosed as chronic hepatitis B and receive nucleos (t) ide analogues
Cohort 3: diagnosed as alcoholic liver injury
Cohort 4: diagnosed as diabetes mellitus and over 50 years of age
Cohort 5: diagnosed as fatty liver and over 50 years of age
2) having no history of hepatocellular carcinoma
3) age at entry is
Cohort1,2,3: 20 years or older and younger than 90 years
Cohort4,5: 50 years or older and younger than 90 years
4)
Cohort1: obtaining sustained viral response by direct-acting antiviral agent
Cohort2: receiving nucleos(t)ide analogue and suppressing HBV-DNA under 3.0 LogIU/mL
Cohort3: consuming alcohol of 60g or more
Key exclusion criteria 1) hepatocellular carcinoma
2) acute hepatitis
3) decompensated liver cirrhosis
4) having an active malignancy
5) serious complications
6) having an infection (except for viral hepatitis)
7) having a psychiatric disorder or psychiatric symptom
8) inappropriate for participant of this study
Target sample size 5800

Research contact person
Name of lead principal investigator
1st name Shuichi
Middle name
Last name Kaneko
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code 920-8641
Address 13-1, Takaramachi, Kanazawa, Ishikawa, Japan
TEL 076-265-2235
Email skaneko@m-kanazawa.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Terashima
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code 920-8641
Address 13-1, Takaramachi, Kanazawa, Ishikawa, Japan
TEL 076-265-2235
Homepage URL
Email tera20jp@gmail.com

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Ethics Committee of Kanazawa University
Address 13-1, Takaramachi, Kanazawa, Ishikawa, Japan
Tel 076-265-2832
Email rinri@adm.kanazawa-u.ac.jp

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
2020 Year 02 Month 12 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
2019 Year 12 Month 03 Day
Date of IRB
2019 Year 12 Month 18 Day
Anticipated trial start date
2020 Year 02 Month 12 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate the usefulness of Laminin2 as predictive factor for the development of hepatocellular carcinoma

Management information
Registered date
2020 Year 02 Month 12 Day
Last modified on
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044956

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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