PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants: Protocol for a Multicenter, Observational Study

Conditions
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Hepatoblastoma, Hepatic Hemangioendothelioma

Intervention / Treatment
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* Diagnostic Test: PIVKA-II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 1 month and 12 month Receiving no treatment before diagnosis With written informed consent Exclusion Criteria: Clinical data missing Serum samples doesn't qualified Vitamin K absence

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hepatoblastoma<br>The diagnosis of hepatoblastoma is based on enhanced CT scanning and/or histopathology. | Diagnostic Test: PIVKA-II<br>* Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.<br>* Other names: DCP;|
| hepatic hemangioendothelioma<br>The diagnosis of hepatic hemangioendothelioma is based on enhanced CT scanning and/or histopathology. | Diagnostic Test: PIVKA-II<br>* Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.<br>* Other names: DCP;|
| Healthy control<br>The healthy control group consist of people undergoing routine medical examination. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of PIVKA-II | Using PIVKA-II assay kit (ARCHITECT I2000SR REFURB, Abbott, America). | Baseline Time, Postoperative Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of AFP | Using the AFP assay (ARCHITECT AFP, Abbott, America). | Baseline Time, Postoperative Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatoblastoma, Hepatic Hemangioendothelioma, Protein induced by vitamin K absence or antagonist-II, Alpha-fetoprotein, infant, Differential diagnosis