UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039425 |
|---|---|
| Receipt number | R000044843 |
| Scientific Title | The observational study to investigate serum carnitine level for patients who will receive HCC treatments and liver transplantation |
| Date of disclosure of the study information | 2020/02/07 |
| Last modified on | 2020/08/11 16:30:36 |
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Basic information
Public title
The observational study to investigate serum carnitine level for patients who will receive HCC treatments and liver transplantation
Acronym
The observational study to investigate serum carnitine level for patients who will receive HCC treatments and liver transplantation
Scientific Title
The observational study to investigate serum carnitine level for patients who will receive HCC treatments and liver transplantation
Scientific Title:Acronym
The observational study to investigate serum carnitine level for patients who will receive HCC treatments and liver transplantation
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate serum carnitine level for patients who will receive HCC treatments and liver transplantation
Basic objectives2
Others
Basic objectives -Others
The possibility to predict the clinical condition with use of the serum carnitine transition
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate serum carnitine level for patients who will receive HCC treatments and liver transplantation
Key secondary outcomes
1) To investigate the factors which correlate with the transition of serum carnitine level.
2) To investigate the factors affecting the transition of serum carnitine level.
3) To investigate the usefulness of serum carnitine as the tumor marker for HCC
4) To investigate the relation with the serum carnitine level and the prognosis.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who will receive HCC treatments or liver transplantation, and older than 20 years
2)Patients who can investigate serum blood tests before and after the treatments
3)Patients who can obtain informed consent
Key exclusion criteria
Patients whom the principal investigator judged as inappropriate for the participation of the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fukumoto |
| Middle name | |
| Last name | Takumi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6302
fukumoto@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Komatsu |
| Middle name | |
| Last name | Shohei |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6302
Homepage URL
komasho8@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School 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
Kobe University Graduate School of Medicine
Address
7-5-2 Kusunoki-cho, Chuo-ku
Tel
0783826302
komasho8@gmail.com
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
| 2020 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2020 | Year | 02 | Month | 07 | Day |
Last modified on
| 2020 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044843
