UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021809
Receipt number R000024075
Scientific Title Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease
Date of disclosure of the study information 2016/04/07
Last modified on 2021/04/05 21:45:05

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Basic information

Public title

Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease

Acronym

Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease

Scientific Title

Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease

Scientific Title:Acronym

Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease

Region

Japan


Condition

Condition

nonalcoholic fatty liver disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the time-dependent change of liver pathogenesis by using MR elastography and transient elastgraphy in patients with nonalcoholic fatty liver disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To assess the time-dependent change of liver fibrosis and liver steatosis by using MR elastography and transient elastgraphy in patients with nonalcoholic fatty liver disease.

Key secondary outcomes

To assess the time-dependent change of liver inflammation and liver iron metabolism by using MR elastography and transient elastgraphy in patients with nonalcoholic fatty liver disease.
To assess the time-dependent change of hematological examination in patients with nonalcoholic fatty liver disease.


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients with suspected NAFLD by interview, blood collection, imaging studies.
2. Patients who are provided a written informed consent, and do not meet the below exclusion criteria.

Key exclusion criteria

1. MRI examination is impossible (ex. Installation of pacemaker, claustrophobia)
2. Pregnant patients
3. In the opinion of the investigator, patient is unsuitable as a study subject.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Ogawa

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

236-0004

Address

3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa

TEL

045-787-2640

Email

ogaway@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Ogawa

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

236-0004

Address

3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa

TEL

045-787-2640

Homepage URL


Email

ogaway@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yokohama City University Graduate School of Medicine

Address

3-9 Fukuura,Kanazawaku, Yokohama

Tel

045-787-2800

Email

ogaway@yokohama-cu.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

横浜市立大学附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 04 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

Completed

Date of protocol fixation

2016 Year 03 Month 01 Day

Date of IRB

2016 Year 03 Month 08 Day

Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2021 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 02 Month 28 Day


Other

Other related information

To assess the time-dependent change of liver pathogenesis by using MR elastography and transient elastgraphy.


Management information

Registered date

2016 Year 04 Month 07 Day

Last modified on

2021 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024075


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name