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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031562
Receipt No. R000035107
Scientific Title Prospective cohort study on novel blood markers in hepatocellular carcinoma
Date of disclosure of the study information 2018/03/05
Last modified on 2018/03/16

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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
Middle name
Last name Yuji Ogawa
Organization Yokohama City University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
Middle name
Last name Yuji Ogawa
Organization Yokohama City University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
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
2018 Year 03 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

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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