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

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.

Conditions

• Hepatoblastoma
• Hepatic Hemangioendothelioma

Interventions

DIAGNOSTIC_TEST

PIVKA-II

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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Chidren's Hospital of Fudan University

  collaborator UNKNOWN

• Chongqing Children's Hospital, Chongqing Medical University

  collaborator UNKNOWN

• Children's Hospital of Nanjing Medical University

  collaborator OTHER

• Qilu Children's Hospital of Shandong University

  collaborator OTHER

• Anhui Children's Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Zhengzhou Children's Hospital

  collaborator UNKNOWN

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Shanghai Children's Medical Center

  lead OTHER

Principal Investigators

• Min Xu, Doctor · Shanghai Children's Medical Center

Eligibility

Min Age

1 Month

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-01

Primary Completion

2020-09-30

Completion

2021-06-30

Countries

• China

Study Locations