Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03047603 |
| Other study ID # |
Pivkaii |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2016 |
| Est. completion date |
March 20, 2019 |
Study information
| Verified date |
February 2024 |
| Source |
Eastern Hepatobiliary Surgery Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The incidence of Hepatocellular carcinoma (HCC) is increasing worldwide. However, most of HCC
cases were at advanced stage when the diagnosis established.Early diagnosis improves the
prognosis.The study is intended to evaluate the diagnostic efficiency of Protein Induced by
Vitamin K Absence or antagonist-II(PIVKA-II). This study is a international multicenter study
joined by several hospitals in China,Singapore,Thailand and Vietnam. Participants including
healthy control,HCC,metastatic liver cancer,Hepatitis B virus(HBV) and liver cirrhosis are
consecutively recruited into the cohort. All the serum samples are collected before any
treatments and will be tested in single center in order to decrease bias. Serum samples were
tested for PIVKA-II,alpha-fetoprotein and biochemical indexes including alanine
aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl
transferase(GGT),alpha-l-fucosidase(AFU),etc.
Description:
Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide.Early
diagnosis improves the prognosis. Protein induced by vitamin K antagonist-II (PIVKA-II), also
known as des-γ-carboxyprothrombin (DCP) or acarboxy prothrombin, is an abnormal form of
prothrombin induced by vitamin K absence or antagonist-II. The study is intended to evaluate
the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(PIVKA-II).
PIVKA-II as an effective tumor marker for hepatocellular carcinoma(HCC) has been widely used
in the western countries where most cases are hepatitis C virus(HCV) related.However, the
majority of HCCs in China are HBV related. Despite the extensive application of PIVKA-II in
some hospitals from China, the diagnostic efficiency including
sensitivity,specificity,positive predictive value and negative predictive value still needs
more clinical data to evaluate. The research purposes list as follows：1.Determination of
diagnostic Cut-off value 2.Evaluation of diagnostic efficiency of PIVKA-II 3.Evaluation of
the combination of PIVKA-II and other tumor markers for HCC. This study is an international
multicenter study joined by several hospitals in China,Singapore,Thailand and Vietnam.
Participants including healthy control,HCC,metastatic liver cancer,HBV and liver cirrhosis
are consecutively recruited into the cohort. All the serum samples are collected before any
treatments and will be tested in single center in order to decrease bias. Serum samples were
tested for PIVKA-II,Alpha-fetoprotein(AFP)，alpha-fetoprotein L3 and biochemical indexes
including ALT,AST,GGT,AFU,etc. The diagnosis of HCC was based on histopathology. All HCC
diagnoses were confirmed at the time of analysis.The Student's t-test (or Mann-Whitney test)
was used to compare continuous variables, and the chi-square test (or Fisher's exact test)
was used for categorical variables. A receiver operator characteristic (ROC) curve was used
to assess the performance characteristic of PIVKA-II,AFP,AFP-L3 measurement.
