UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000008474