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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039425
Receipt No. 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 2020/02/07

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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
Email 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
Email komasho8@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
Email 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 Preinitiation
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 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044843

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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