UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036367 |
|---|---|
| Receipt number | R000041432 |
| Scientific Title | The analysis of urine Titin-N fragment concentration among the patients with chronic liver disease |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2024/04/04 12:10:51 |
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Basic information
Public title
The analysis of urine Titin-N fragment concentration among the patients with chronic liver disease
Acronym
The analysis of urine Titin-N fragment concentration among the patients with chronic liver disease
Scientific Title
The analysis of urine Titin-N fragment concentration among the patients with chronic liver disease
Scientific Title:Acronym
The analysis of urine Titin-N fragment concentration among the patients with chronic liver disease
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To figure out the meaning of the measurement of urine Titin-N fragment concentration among the patients with chronic liver disease
Basic objectives2
Others
Basic objectives -Others
To observe the time-course change of the urine Titin-N fragment concentration among the patients with chronic liver disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time-course change of urine Titin-N fragment concentration among the patients with chronic liver disease
Key secondary outcomes
Time-course change of skeletal muscle mass and grip strength among the patients with chronic liver disease
The long-term frequency of sarcopenia among the patients with chronic liver disease
The correlation between the urine Titin-N fragment concentration and the frequency of sarcopenia among the patients with chronic 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Chronic liver disease
Key exclusion criteria
Judged by investigator not to be appropriate for inclusion in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Atsukawa |
Organization
Nippon medical school
Division name
Division of Gastroenterology and Hepatology
Zip code
1138603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
0338222131
momogachi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Chisa |
| Middle name | |
| Last name | Kondo |
Organization
Nippon medical school Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
2701694
Address
1715, Inzai, Kamakari, Chiba, Japan
TEL
0476991111
Homepage URL
s8042@nms.ac.jp
Sponsor or person
Institute
Nippon medical school Chiba Hokusoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Chiba Hokusoh Hospital Institutional Review Board
Address
270-1694 1715, Kamakari, Inzai, Chiba, Japan
Tel
0476991111
araraki@nms.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
| 2019 | Year | 04 | 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
79
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
| 2018 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is the observational study to investigate the relationships between urinary Titin-N fragment concentration and fibrosis markers, grip strength or skeletal muscle mass among the patients with chronic liver disease.
Management information
Registered date
| 2019 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041432
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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