PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants
- Conditions
- HepatoblastomaHepatic Hemangioendothelioma
- Interventions
- Diagnostic Test: PIVKA-II
- Registration Number
- NCT03645655
- Lead Sponsor
- Shanghai Children's Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
- Age between 1 month and 12 month
- Receiving no treatment before diagnosis
- With written informed consent
- Clinical data missing
- Serum samples doesn't qualified
- Vitamin K absence
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description hepatic hemangioendothelioma PIVKA-II The diagnosis of hepatic hemangioendothelioma is based on enhanced CT scanning and/or histopathology. hepatoblastoma PIVKA-II The diagnosis of hepatoblastoma is based on enhanced CT scanning and/or histopathology.
- Primary Outcome Measures
Name Time Method Change of PIVKA-II Baseline Time, Postoperative Day 1 Using PIVKA-II assay kit (ARCHITECT I2000SR REFURB, Abbott, America).
- Secondary Outcome Measures
Name Time Method Change of AFP Baseline Time, Postoperative Day 1 Using the AFP assay (ARCHITECT AFP, Abbott, America).
Trial Locations
- Locations (1)
Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China