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

Hepatoblastoma Clinical Trial

— PIVKA-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645655
• Other study ID #: General surgery of SCMC
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Shanghai Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: June 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Hemangioendothelioma
• Hepatic Hemangioendothelioma
• Hepatoblastoma
• Liver Neoplasms

Intervention

Diagnostic Test:
• PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (10)

Lead Sponsor

Collaborator

Shanghai Children's Medical Center

Anhui Children's Hospital, Chidren's Hospital of Fudan University, Children's Hospital of Nanjing Medical University, Chongqing Children's Hospital, Chongqing Medical University, Qilu Children's Hospital of Shandong University, Sun Yat-sen Memorial Hospital,Sun Yat-sen University, The First Affiliated Hospital of Anhui Medical University, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Zhengzhou Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of PIVKA-II	Using PIVKA-II assay kit (ARCHITECT I2000SR REFURB, Abbott, America).	Baseline Time, Postoperative Day 1
Secondary	Change of AFP	Using the AFP assay (ARCHITECT AFP, Abbott, America).	Baseline Time, Postoperative Day 1