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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03460080
• Other study ID #: HMU16222
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2018
• Last updated: March 2, 2018
• Start date: January 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2018
• Source: Hanoi Medical University
• Contact: n/a
• Is FDA regulated: No
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• AFP-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

Locations

Country	Name	City	State
Vietnam	Hanoi Medical University	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Hanoi Medical University	Bach Mai Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PIVKA-II	Using PIVKA-II assay kit (chemiluminescent microparticle immunoassay)	Day one
Secondary	Alpha-Fetoprotein (AFP)	Using chemiluminescent microparticle immunoassay to measure AFP levels	Day one
Secondary	Alpha-Fetoprotein-L3% (AFP-L3%)	Using µTASWako i30 automated immunoassay analyzer to measure AFP-L3% levels	Day one
Secondary	Alanine Aminotransferase (ALT)	Using Abbott Architect automated immunoassay analyzer to measure ALT levels	Day one
Secondary	Aspartate Aminotransferase (AST)	Using Abbott Architect automated immunoassay analyzer to measure AST levels	Day one
Secondary	Gamma Glutamyl Transferase (?-GT)	Using Abbott Architect automated immunoassay analyzer to measure ?-GT levels	Day one
Secondary	Hepatitis B virus surface antigen (HBsAg)	Using Abbott Architect automated immuno-analyzer to measure HBsAg levels	Day one
Secondary	Antibodies to Hepatitis C virus (Anti HCV)	Using Abbott Architect automated immunoassay analyzer to measure Anti HCV levels	Day one
Secondary	Albumin	Using Abbott Architect automated immunoassay analyzer to measure Albumin levels	Day one
Secondary	Prothrombin Time (PT) (%)	Using Abbott Architect automated immunoassay analyzer to measure PT (%)	Day one