UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033550 |
|---|---|
| Receipt number | R000038258 |
| Scientific Title | Measurement of Carbohydrate-deficient transferrin in chronic liver disease; the prospective study |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2025/01/31 14:39:54 |
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Basic information
Public title
Measurement of Carbohydrate-deficient transferrin in chronic liver disease; the prospective study
Acronym
Measurement of Carbohydrate-deficient transferrin in chronic liver disease; the prospective study
Scientific Title
Measurement of Carbohydrate-deficient transferrin in chronic liver disease; the prospective study
Scientific Title:Acronym
Measurement of Carbohydrate-deficient transferrin in chronic liver disease; the prospective study
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 analyze the correlation of measured value of CDT and amount of drinking
Basic objectives2
Others
Basic objectives -Others
to confirm the usefulness of CDT in diagnosis of liver diseases
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
measured value of CDT
Key secondary outcomes
pathological findings of liver biopsy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
liver biopsy
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
1.the patients who agree with participation in this study by their free will and write the agreement document as well after they are explained enough about the study.
2.the patients whose amount of drinking is well-defined.
Key exclusion criteria
1.the patients whose amount of drinking in not well-defined.
2.the patients who are judged inappropriate for this study by the principal investigator.
3.the patients who refuse to participate in this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Ikejima |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
ikejima@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Ikejima |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Homepage URL
ikejima@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Juntendo hospital IRB
Address
3-1-3 Hongo Bunkyo-ku Tokyo, Japan
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
順天堂大学医学部消化器内科（東京都）、順天堂大学医学部附属練馬病院（東京都）、順天堂大学医学部附属浦安病院（千葉県）、順天堂大学医学部附属静岡病院（静岡県）、東部地域病院（東京都）、順天堂大学医学部附属東京江東高齢者医療センター（東京都）、東京臨海病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35060066/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35060066/
Number of participants that the trial has enrolled
120
Results
A total of 120 patients diagnosed with fatty liver were interviewed about their alcohol consumption using AUDIT, and the diagnostic performance of the amount of alcohol consumed by %CDT, MCV, and GGT was compared. The diagnostic ability to detect non- to light drinkers was 1.78% (AUROC 0.851). The diagnostic ability to detect heavy drinking was 2.08%. %CDT is an excellent marker that was not affected by liver damage, liver steatosis/stiffness, and metabolic syndrome-related factors.
Results date posted
| 2025 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
120 patients aged 23 to 87 years who were admitted to Juntendo University hospital between September 2018 and October 2020 and were diagnosed with fatty liver disease,
Participant flow
Patients diagnosed with fatty liver are interviewed about the amount of alcohol consumed using AUDIT, and various drinking markers, such as %CDT, MCV, GGT, are measured.
Adverse events
none
Outcome measures
Ability to detect the amount of alcohol consumed by %CDT, GGT, MCV,
Correlation of each drinking marker with metabolic syndrome-related factors, liver enzyme levels, liver hardness and liver adiposity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038258
