UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study on novel blood markers in hepatocellular carcinoma
Acronym	Prospective cohort study on novel blood markers in hepatocellular carcinoma
Scientific Title	Prospective cohort study on novel blood markers in hepatocellular carcinoma
Scientific Title:Acronym	Prospective cohort study on novel blood markers in hepatocellular carcinoma
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Research for blood markers for hepatocellular carcinoma in each etiology.
Basic objectives2	Others
Basic objectives -Others	Diagnosis
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To elucidate the blood marker in diagnosis of hepatocellular carcinoma by proteomics analysis, metabolomics analysis, and miRNA analysis using serum and plasma of patients with hepatocellular carcinoma.
Key secondary outcomes	1) To elucidate the blood marker in diagnosis of hepatocellular carcinoma by individual protein expression analysis and individual miRNA analysis using serum and plasma of patients with hepatocellular carcinoma. 2) Abdominal skeletal muscle mass analysis using CT/MRI image at diagnosis of hepatocellular carcinoma

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with diagnosed hepatocellular carcinoma by blood collection and imaging studies.
Key exclusion criteria	1) Persons judged inappropriate for this study
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Ogawa
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2640
Email	ogaway@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Ogawa
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2640
Homepage URL
Email	ogaway@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
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	Yokohama City University School of medicine
Address	3-9 Fukuura, Kanazawaku
Tel	0457872640
Email	ogaway@yokohama-cu.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	2018 Year 03 Month 05 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	Completed
Date of protocol fixation	2017 Year 01 Month 09 Day
Date of IRB	2018 Year 05 Month 07 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2021 Year 01 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is observational study. Analysis is conducted prospectively with the samples collected after the date of registration.

Management information
Registered date	2018 Year 03 Month 03 Day
Last modified on	2021 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035107