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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036367
Receipt No. 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 2021/06/23

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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
Email 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
Email s8042@nms.ac.jp

Sponsor
Institute Nippon medical school Chiba Hokusoh Hospital
Institute
Department

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
Email 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
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 No longer recruiting
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
2021 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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