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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036175
Receipt No. R000041212
Scientific Title Research to narrow down patients with liver cirrhosis hidden from health checkup examinees
Date of disclosure of the study information 2019/04/01
Last modified on 2020/09/12

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Basic information
Public title Research to narrow down patients with liver cirrhosis hidden from health checkup examinees
Acronym Research to narrow down patients with liver cirrhosis hidden from health checkup examinees
Scientific Title Research to narrow down patients with liver cirrhosis hidden from health checkup examinees
Scientific Title:Acronym Research to narrow down patients with liver cirrhosis hidden from health checkup examinees
Region
Japan

Condition
Condition Liver cirrhosis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 narrowing down liver cirrhosis from medical checkup examinee using measurement of WFA+-M2BP
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic accuracy of liver cirrhosis
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
100 years-old >
Gender Male and Female
Key inclusion criteria Medical examination examinee of age 20 years or older
Patients who obtained written informed consent
Key exclusion criteria Patients with HCV, HBV, AIH and PBC
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Kurosaki
Organization Musashino Red Cross Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 180-8610
Address 1-26-1, Kyonancho, Musashinoshi, Tokyo
TEL +81-422-32-3111
Email kurosaki@musashino.jrc.or.jp

Public contact
Name of contact person
1st name Nobuharu
Middle name
Last name Tamaki
Organization Musashino Red Cross Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 180-8610
Address 1-26-1, Kyonancho, Musashinoshi, Tokyo
TEL +81-422-32-3111
Homepage URL
Email tamaki@musashino.jrc.or.jp

Sponsor
Institute Musashino Red Cross Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Musashino Red Cross Hospital clinical research ethics committee
Address 1-26-1, Kyonancho, Musashinoshi, Tokyo
Tel +81-422-32-3111
Email shomu2@musashino.jrc.or.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
2019 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 2021
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 No longer recruiting
Date of protocol fixation
2019 Year 01 Month 30 Day
Date of IRB
2019 Year 01 Month 30 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 03 Month 12 Day
Last modified on
2020 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041212

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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