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Diagnostic Value of AFP-L3 and PIVKA-II in HCC

Diagnostic Value of AFP-L3 and PIVKA-II in HCC

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03460080
Enrollment
200
Registered
2018-03-09
Start date
2018-01-01
Completion date
2018-12-01
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, AFP-L3, PIVKA-II

Brief 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 alpha-fetoprotein-L3 (AFP-L3) and Protein Induced by Vitamin K Absence or antagonist-II (PIVKA-II). This study is performed at Hanoi Medical University Hospital. Participants including patients with HCC and hepatic hemangioma. 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, AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.

Detailed 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 AFP-L3 and PIVKA-II. AFP-L3 and PIVKA-II as an effective tumor marker for hepatocellular carcinoma(HCC). Despite the extensive application of PIVKA-II in some hospitals from Vietnam, 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 changes in AFP-L3 and PIVKA II for HCC.2. Investigating the diagnostic value of AFP-L3 and PIVKA II for HCC. This study is performed at Hanoi Medical University Hospital. Participants including patients with HCC and hepatic hemangioma. 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, AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.The diagnosis of HCC was based on HCC criteria of Ministry of Public Health of Vietnam. All HCC diagnoses were confirmed at the time of analysis. Stages of tumor is evaluated by Barcelana classification. 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.

Interventions

DIAGNOSTIC_TESTAFP-L3 and PIVKA-II in HCC

Serum samples are tested for tumor markers including PIVKA-II, AFP, AFP-L3% and biochemical tests. Imaging: CT or MRI

Sponsors

Hanoi Medical University
Lead SponsorOTHER
Bach Mai Hospital
CollaboratorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Age between 18 and 85 * Receiving no treatment before diagnosis * Establishing Diagnosis according to thecriteria of Ministry of Public Health of Vietnam 2012.

Exclusion criteria

* Clinical data missing * Laboratory tests information missing * Serum samples doesn't qualified * Obstructive jaundice patients * Medical history of taking warfarin

Design outcomes

Primary

MeasureTime frameDescription
PIVKA-IIDay oneUsing PIVKA-II assay kit (chemiluminescent microparticle immunoassay)

Secondary

MeasureTime frameDescription
Alpha-Fetoprotein (AFP)Day oneUsing chemiluminescent microparticle immunoassay to measure AFP levels
Alpha-Fetoprotein-L3% (AFP-L3%)Day oneUsing µTASWako i30 automated immunoassay analyzer to measure AFP-L3% levels
Alanine Aminotransferase (ALT)Day oneUsing Abbott Architect automated immunoassay analyzer to measure ALT levels
Aspartate Aminotransferase (AST)Day oneUsing Abbott Architect automated immunoassay analyzer to measure AST levels
Gamma Glutamyl Transferase (γ-GT)Day oneUsing Abbott Architect automated immunoassay analyzer to measure γ-GT levels
Hepatitis B virus surface antigen (HBsAg)Day oneUsing Abbott Architect automated immuno-analyzer to measure HBsAg levels
Antibodies to Hepatitis C virus (Anti HCV)Day oneUsing Abbott Architect automated immunoassay analyzer to measure Anti HCV levels
AlbuminDay oneUsing Abbott Architect automated immunoassay analyzer to measure Albumin levels
Prothrombin Time (PT) (%)Day oneUsing Abbott Architect automated immunoassay analyzer to measure PT (%)

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026