Clinical trial NCT03460080: Diagnostic Value of AFP-L3 and PIVKA-II in HCC
Official title: Diagnostic Value of AFP-L3 and PIVKA-II in HCC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
AFP-L3
PIVKA-II
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: Bach Mai Hospital
First posted: 2018-03-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The participants will be recruited through outpatient clinics and inpatient in Hanoi Medical University Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PIVKA-II
timeFrame: Day one
Secondary outcomes:
measure: Alpha-Fetoprotein (AFP)
timeFrame: Day one
measure: Alpha-Fetoprotein-L3% (AFP-L3%)
timeFrame: Day one
measure: Alanine Aminotransferase (ALT)
timeFrame: Day one
measure: Aspartate Aminotransferase (AST)
timeFrame: Day one
measure: Gamma Glutamyl Transferase (γ-GT)
timeFrame: Day one
measure: Hepatitis B virus surface antigen (HBsAg)
timeFrame: Day one
measure: Antibodies to Hepatitis C virus (Anti HCV)
timeFrame: Day one
measure: Albumin
timeFrame: Day one
measure: Prothrombin Time (PT) (%)
timeFrame: Day one
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
Study officials:
References: