UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007196 |
|---|---|
| Receipt number | 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 17:23:23 |
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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
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
hiasa@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008474
