UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044843