UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012757
Receipt number R000014860
Scientific Title Assessment of liver pathogenesis by MR elastography in chronic liver diseases
Date of disclosure of the study information 2014/01/06
Last modified on 2019/05/06 15:12:19

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Basic information

Public title

Assessment of liver pathogenesis by MR elastography in chronic liver diseases

Acronym

Assessment of liver pathogenesis by MR elastography in chronic liver diseases(MRELAST STUDY)

Scientific Title

Assessment of liver pathogenesis by MR elastography in chronic liver diseases

Scientific Title:Acronym

Assessment of liver pathogenesis by MR elastography in chronic liver diseases(MRELAST STUDY)

Region

Japan


Condition

Condition

Patients with chronic liver diseases

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prove that MR elastography is useful for diagnosis of liver pathogenesis in patients with chronic liver diseases.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To assess whether MR elastography is useful for diagnosis of liver inflammation and fibrosis in patients with chronic 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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who are scheduled to undergo liver biopsy or hepatectomy at our institution, provide a written informed consent, and do not meet the below exclusion criteria.

Key exclusion criteria

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

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Nakajima

Organization

Yokohama City University Graduate School of Medicine

Division name

Division of Gastroenterology

Zip code

236-0004

Address

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

TEL

045-787-2640

Email

nakajima-tky@umin.ac.jp


Public contact

Name of contact person

1st name Kento
Middle name
Last name Imajo

Organization

Yokohama City University Graduate School of Medicine

Division name

Division of Gastroenterology

Zip code

236-0004

Address

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

TEL

045-787-2640

Homepage URL


Email

kento318@yohohama-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

Other

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

Yokohama City University Graduate School of Medicine

Tel

045-787-2800

Email

kento318@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



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 06 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

2013 Year 12 Month 25 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To assess whether MR elastography is useful for diagnosis of liver inflammation and fibrosis in patients with chronic liver diseases.


Management information

Registered date

2014 Year 01 Month 05 Day

Last modified on

2019 Year 05 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014860


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name