MedTrace Logo

Evaluation of Diagnostic Efficiency of PIVKA-II and Other Tumor Markers in HCC

NCT03047603 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4005

Last updated 2024-02-20

No results posted yet for this study

Summary

The incidence of Hepatocellular carcinoma (HCC) is increasing worldwide. However, most of HCC cases were at advanced stage when the diagnosis established.Early diagnosis improves the prognosis.The study is intended to evaluate the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(PIVKA-II). This study is a international multicenter study joined by several hospitals in China,Singapore,Thailand and Vietnam. Participants including healthy control,HCC,metastatic liver cancer,Hepatitis B virus(HBV) and liver cirrhosis are consecutively recruited into the cohort. All the serum samples are collected before any treatments 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

Interventions

DIAGNOSTIC_TEST

PIVKA-II

Serum samples are tested for tumor markers including PIVKA-II,AFP,AFP-L3% and biochemical tests.

Sponsors & Collaborators

  • Abbott Diagnostics Division

    collaborator INDUSTRY

  • Peking University First Hospital

    collaborator OTHER

  • The First Hospital of Jilin University

    collaborator OTHER

  • RenJi Hospital

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Gansu Provincial Hospital

    collaborator OTHER

  • Henan Provincial People's Hospital

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Sichuan Provincial People's Hospital

    collaborator OTHER

  • Eastern Hepatobiliary Surgery Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2018-09-01
Completion
2019-03-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03047603 on ClinicalTrials.gov