UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036699 |
|---|---|
| Receipt number | R000041818 |
| Scientific Title | Usefulness of serum Mac-2 binding protein glycosylation isomer in patients undergoing hepatectomy |
| Date of disclosure of the study information | 2019/05/10 |
| Last modified on | 2019/05/10 10:40:52 |
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Basic information
Public title
Usefulness of serum Mac-2 binding protein glycosylation isomer in patients undergoing hepatectomy
Acronym
Usefulness of M2BPGi in patients undergoing hepatectomy
Scientific Title
Usefulness of serum Mac-2 binding protein glycosylation isomer in patients undergoing hepatectomy
Scientific Title:Acronym
Usefulness of M2BPGi in patients undergoing hepatectomy
Region
| Japan |
Condition
Condition
The patients with liver diseases who were undergoing hepatic resections
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the feasibility and limitations of serum Mac-2 binding protein glycosylation isomer as a supportive diagnostic modality in liver surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the usefulness of Mac-2 binding protein glycosylation isomer to predict the morbidity after hepatectomy.
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 patients with liver diseases who were undergoing hepatic resections.
Key exclusion criteria
The patients who refuse to join in this study.
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nanashima |
Organization
Department of Surgery, University of Miyazak,i Faculty of Medicine
Division name
Division of Hepato-biliary-Pancreatic Surgery
Zip code
889-1692
Address
Kihara 5200, Kiyotake, Miyazaki, Japan
TEL
0985-85-2808
a_nanashima@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Hiyoshi |
Organization
Department of Surgery, University of Miyazaki, Faculty of Medicine
Division name
Division of Hepato-biliary-Pancreatic Surgery
Zip code
889-1692
Address
Kihara 5200, Kiyotake, Miyazaki, Japan
TEL
0985-85-2808
Homepage URL
mhiyoshi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki, Faculty of Medicine
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
Reserch Ethics Committee, Faculty of Medicine, University of Midicine
Address
Kihara 5200, Kiyotake, Miyazaki, Japan
Tel
0985-85-9403
rinken@med.miyazaki-u.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 | 05 | Month | 10 | 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
115
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
Main results already published
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyzed the data and submitted the paper.
Management information
Registered date
| 2019 | Year | 05 | Month | 10 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041818
| Research Plan | |
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| 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 |
