UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017343
Receipt number R000020121
Scientific Title Search of biomarkers for metabolic abnormalities of cholesterol by comprehensive analysis of cholesterol metabolites in human body fluid
Date of disclosure of the study information 2015/05/01
Last modified on 2015/04/30 16:00:54

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Basic information

Public title

Search of biomarkers for metabolic abnormalities of cholesterol by comprehensive analysis of cholesterol metabolites in human body fluid

Acronym

Search of biomarkers for cholesterol metabolic abnormalirties

Scientific Title

Search of biomarkers for metabolic abnormalities of cholesterol by comprehensive analysis of cholesterol metabolites in human body fluid

Scientific Title:Acronym

Search of biomarkers for cholesterol metabolic abnormalirties

Region

Japan


Condition

Condition

Inborn error of metabolism (Niemann-Pick disease type C, 3beta-hydroxy-delta5-C27-steroid dehydrogenase/isomerase (3beta-HSD) defficiency, lysosomal storage disorder, etc), hepatobiliary diaseses (steatosis, NAFLD, NASH, ALD, hepatitis B, hepatitis C, primary biliary cirrhosis, cholangitis, hepatic carcinoma)

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Pediatrics
Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Many report of the variaton of cholesterol metabolite profile in hepatobiliary diseases and inborn errors of metabolism have been published. The qualitative and quantitative variation of them are variable, so, it is probable for finding disease specific biomarkers for cholesterol metabolic diseases. The aim of this study is the searching of the diaseses by comprehensive analysis of cholesterol metabolites.

Basic objectives2

Others

Basic objectives -Others

Diagnosis

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

m/z and peak intensity of cholesterol metebolites

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patient of inborn error of metabolism (Niemann-Pick disease type C, 3beta-hydroxy-delta5-C27-steroid dehydrogenase/isomerase (3beta-HSD) defficiency, lysosomal storage disorder, etc), and hepatobiliary diaseses (steatosis, NAFLD, NASH, ALD, hepatitis B, hepatitis C, primary biliary cirrhosis, cholangitis, hepatic carcinoma).

Key exclusion criteria

No

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nariyasu Mano

Organization

Tohoku university hospital

Division name

Department of pharmaceutical sciences

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7525

Email

mano@hosp.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masamitsu Maekawa

Organization

Tohoku university hospital

Division name

Department of pharmaceutical sciences

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7541

Homepage URL


Email

m-maekawa@hosp.tohoku.ac.jp


Sponsor or person

Institute

Department of Pharmaceutical Sciences, Tohoku university hospital

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Division of hepatology, Tohoku university hospital,
Division of pediatrics, Tohoku university hospital,
Junshin clinic, bile acid institute,
Sanin rosai hospital,
Department of child neurology, Tottori university,
Division of pediatrics, Kumamoto university,
Department of Neurology, Jichi medical university, Saitama medical center,
Dokkyo university school of medicine,
Advanced clinical research center, Institute of neurological disorders,
Jichi Medical University
Kanagawa Children's Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 05 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

Open public recruiting

Date of protocol fixation

2013 Year 09 Month 13 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The peaks of cholesterol metabolites in body fluid of various patients and healthy volunteers were analyzed by LC/MS/MS.


Management information

Registered date

2015 Year 04 Month 30 Day

Last modified on

2015 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020121


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name