UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041609
Receipt number R000047472
Scientific Title Research to narrow down patients with liver cirrhosis hidden in health checkup examinees
Date of disclosure of the study information 2020/09/01
Last modified on 2021/08/31 13:55:30

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Basic information

Public title

Research to narrow down patients with liver cirrhosis hidden in health checkup examinees

Acronym

Research to narrow down patients with liver cirrhosis hidden in health checkup examinees

Scientific Title

Research to narrow down patients with liver cirrhosis hidden in health checkup examinees

Scientific Title:Acronym

Research to narrow down patients with liver cirrhosis hidden in health checkup examinees

Region

Japan


Condition

Condition

Liver cirrhosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

narrowing down liver cirrhosis from medical checkup examinee using measurement of ultrasound elastography

Basic objectives2

Others

Basic objectives -Others

Observating outcoome of this study cohort for 3-5 years

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Diagnostic accuracy of liver cirrhosis

Key secondary outcomes

survival, liver carcinogenesis, cirrhosis


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 Sakura
Middle name
Last name Kirino

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

sa.kirino@musashino.jrc.or.jp


Sponsor or person

Institute

Musashino Red Cross Hospital

Institute

Department

Personal name



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

2020 Year 09 Month 01 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

No longer recruiting

Date of protocol fixation

2020 Year 07 Month 14 Day

Date of IRB

2020 Year 07 Month 14 Day

Anticipated trial start date

2020 Year 09 Month 01 Day

Last follow-up date

2025 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 08 Month 30 Day

Last modified on

2021 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047472


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name