PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants
Condition: Hepatoblastoma; Hepatic Hemangioendothelioma
MeSH terms: Hepatoblastoma; Hemangioendothelioma; Liver Neoplasms
Study type: Observational

Summary: 
      Although hepatic tumors are uncommon in the perinatal period they are associated with
      significant morbidity and mortality in affected patients. The study is intended to evaluate
      the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(PIVKA-II)
      combining with alpha-fetoprotein in hepatic tumor of infant. This study is a multicenter
      study joined by several hospitals in China. Participants including hepatoblastoma, hepatic
      hemangioendothelioma and healthy control are consecutively recruited into the cohort. All the
      serum samples are collected before and after each treatment 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.
    

Detailed description: 
      Hepatic tumors seldom occur in the perinatal period. They comprise approximately 5% of the
      total neoplasms of various types occurring in the fetus and neonate. Infantile
      hemangioendothelioma is the leading primary hepatic tumor followed by hepatoblastoma.
      Although alpha-fetoprotein has been well recognized as biomarker of hepatic tumors, it should
      be mentioned that this protein in normal infants is highly elevated during the first 2 months
      of life.

      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. An elevated serum level of PIVKA-II is reported to be associated
      with hepatocellular (HCC). Many studies have shown that PIVKA-II is applicable for HCC
      surveillance and has been written into the guideline of JSH, which achieves remarkably good
      results.

      The study is intended to evaluate diagnostic and differential diagnostic accuracy of PIVKA-II
      combining with alpha-fetoprotein in hepatic tumor of infant.

      This study is a multicenter study joined by several hospitals in China. Participants
      including hepatoblastoma, hepatic hemangioendothelioma and healthy control. All the serum
      samples are collected before and after each treatment and will be tested in single center in
      order to decrease bias. Serum samples were tested for PIVKA-II, Alpha-fetoprotein(AFP)， and
      biochemical indexes including ALT, AST, GGT, AFU, etc. The diagnosis of hepatoblastoma and
      hepatic hemangioendothelioma was based on enhanced CT scanning and/or histopathology. 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 diagnostic and differential
      diagnostic efficiency of PIVKA-II and the combined tumor markers with AFP.
    

Intervention name(s): PIVKA-II
Intervention type(s): Diagnostic Test
Intervention description(s): Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.
Other intervention name(s): DCP
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The participants will be recruited through inpatient department.
      
Biospecimen description: 
      Peripheral blood was collected from each patient prior to any treatment (surgery and/or
      chemotherapy)
    
Keywords: hepatoblastoma; Hepatic Hemangioendothelioma; Protein induced by vitamin K absence or antagonist-II; Alpha-fetoprotein; infant; Differential diagnosis