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
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
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
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
