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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007196
Receipt No. R000008474
Scientific Title Clinical verification of an improved assay of "NX-PVKA-R", which associated with des-gamma-carboxyprothrombin, for diagnosis of patients with hepatocellular carcinoma
Date of disclosure of the study information 2012/02/01
Last modified on 2019/08/16

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Basic information
Public title Clinical verification of an improved assay of "NX-PVKA-R", which associated with des-gamma-carboxyprothrombin, for diagnosis of patients with hepatocellular carcinoma
Acronym Clinical verification of an improved assay of "NX-PVKA-R" for HCC
Scientific Title Clinical verification of an improved assay of "NX-PVKA-R", which associated with des-gamma-carboxyprothrombin, for diagnosis of patients with hepatocellular carcinoma
Scientific Title:Acronym Clinical verification of an improved assay of "NX-PVKA-R" for HCC
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Des-gamma-prothrombin (DCP) is an established tumor marker of hepatocellular carcinoma (HCC). The serum level of DCP increases in non-specific conditions other than HCC since DCP is produced in the absence of vitamin K, or in case its action is antagonized by vitamin K antagonist. We will verify the improved assay kit of des-gamma-prothorombin, named as "NX-PVKA-R" to diagnose HCC by using the serum of patients with and without HCC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivity and specificity of PIVKA-II, NX-PVKA, NX-PVKA-R and AFP to diagnose HCC
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with chronic hepatitis, hepatocirrhosis, or treatment-naive hepatocellular carcinoma.
2. Protein induced by vitamin K absence or antagonist-II (PIVKA-II) is measured by the conventional method. The patients, whose level of PIVKA-II was higher than 40mU/mL or lower or equal to 40mU/mL, can enroll for this study.
Key exclusion criteria 1. The patients who have poorly controlled cardiovascular, hematologic or pulmonary disease
2. The patients with pregnancy
3. The patients with severe depression or other psychiatric disorders
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Hiasa
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL +81-89-960-5308
Email hiasa@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Hiasa
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL +81-89-960-5308
Homepage URL
Email hiasa@m.ehime-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (Japan Society for the Promotion of Science, KAKENHI) from the Ministry of Education, Culture, Sports, Science and Technology, Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2012 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 05 Month 24 Day
Date of IRB
2010 Year 05 Month 01 Day
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2019 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation of clinical background for the patients with HCC, who have high levels of PIVKA-II, AFP or NX-PVKA-R.

Management information
Registered date
2012 Year 02 Month 01 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008474

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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