UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031562 |
|---|---|
| Receipt number | 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 | 2021/01/16 13:50:01 |
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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 | 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
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
ogaway@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035107
