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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016153
Receipt No. R000018752
Scientific Title Development of Quick, Easy and Inexpensive Serum Biomarker for Liver Disease
Date of disclosure of the study information 2015/01/07
Last modified on 2019/07/12

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Basic information
Public title Development of Quick, Easy and Inexpensive Serum Biomarker for Liver Disease
Acronym Serum Biomarkers for Liver Disease
Scientific Title Development of Quick, Easy and Inexpensive Serum Biomarker for Liver Disease
Scientific Title:Acronym Serum Biomarkers for Liver Disease
Region
Japan

Condition
Condition Chronic Liver Disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Development of serum biomarkers useful for diagnosis of liver cirrhosis and early detection of liver cancer
Basic objectives2 Others
Basic objectives -Others Evaluation of serum biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between serum biomakers and progress of liver diseases
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with chronic liver disease and/or liver cancer
Patients who can give a written consent to the entry of the study.
Patients of 20 years old and over without distinction of gender.
Key exclusion criteria Patients who are under 20 years of age.
Patients who are not considered to be eligible for the study by the doctor's judgment.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kazuyoshi
Middle name
Last name Kon
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code 113-8421
Address 2-1-1 Hongo Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kazukon@juntendo.ac.jp

Public contact
Name of contact person
1st name Kazuyoshi
Middle name
Last name Kon
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code 113-8421
Address 2-1-1 Hongo Bunkyo-ku, Tokyo
TEL 03-3813-31111
Homepage URL
Email kazukon@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Juntendo University Hospital
Address 2-1-1 Hongo, Bunkyo-ku
Tel 03-5802-1584
Email chiken@juntendo.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 順天堂大学附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 07 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 25 Day
Date of IRB
2009 Year 01 Month 05 Day
Anticipated trial start date
2016 Year 10 Month 03 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information Prospective study

Management information
Registered date
2015 Year 01 Month 07 Day
Last modified on
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018752

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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