UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016153 |
|---|---|
| Receipt number | R000018752 |
| Scientific Title | Development of Quick, Easy and Inexpensive Serum Biomarker for Liver Disease |
| Date of disclosure of the study information | 2015/01/07 |
| Last modified on | 2021/06/09 19:24:14 |
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Basic information
Public title
Development of Quick, Easy and Inexpensive Serum Biomarker for Liver Disease
Acronym
Serum Biomarkers for Liver Disease
Scientific Title
Development of Quick, Easy and Inexpensive Serum Biomarker for Liver Disease
Scientific Title:Acronym
Serum Biomarkers for Liver Disease
Region
| Japan |
Condition
Condition
Chronic Liver Disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of serum biomarkers useful for diagnosis of liver cirrhosis and early detection of liver cancer
Basic objectives2
Others
Basic objectives -Others
Evaluation of serum biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between serum biomakers and progress of 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic liver disease and/or liver cancer
Patients who can give a written consent to the entry of the study.
Patients of 20 years old and over without distinction of gender.
Key exclusion criteria
Patients who are under 20 years of age.
Patients who are not considered to be eligible for the study by the doctor's judgment.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Kon |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
kazukon@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Kon |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku, Tokyo
TEL
03-3813-31111
Homepage URL
kazukon@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
2-1-1 Hongo, Bunkyo-ku
Tel
03-5802-1584
kenkyu5858@juntendo.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
順天堂大学附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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 | 09 | Month | 25 | Day |
Date of IRB
| 2009 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018752
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
