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NCT Number: NCT03645655

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

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.

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Key information

Conditions

Hepatoblastoma Hepatic Hemangioendothelioma Neoplasms Neoplasms by Histologic Type Neoplasms, Complex and Mixed

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PIVKA-II

Diagnostic Test

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

Other names: DCP

Primary outcomes

  1. Change of PIVKA-II

    Time frame: Baseline Time, Postoperative Day 1

    Using PIVKA-II assay kit (ARCHITECT I2000SR REFURB, Abbott, America).

Secondary outcomes

  1. Change of AFP

    Time frame: Baseline Time, Postoperative Day 1

    Using the AFP assay (ARCHITECT AFP, Abbott, America).

Sponsors and collaborators

Lead sponsor

Shanghai Children's Medical Center

Other

Collaborators

  • Anhui Children's Hospital
  • Chidren's Hospital of Fudan University
  • Children's Hospital of Chongqing Medical University
  • Children's Hospital of Nanjing Medical University
  • Qilu Children's Hospital of Shandong University
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital of Anhui Medical University
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Zhengzhou Children's Hospital

Registry information

Official study title

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

Acronym: PIVKA-II

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 24, 2018
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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