Diagnostic Value of AFP-L3 and PIVKA-II in HCC

NCT ID: NCT03460080

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-01

Brief 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 alpha-fetoprotein-L3 (AFP-L3) and Protein Induced by Vitamin K Absence or antagonist-II (PIVKA-II). This study is performed at Hanoi Medical University Hospital. Participants including patients with HCC and hepatic hemangioma. 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, AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.

Detailed Description

Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide.Early diagnosis improves the prognosis. 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. The study is intended to evaluate the diagnostic efficiency of AFP-L3 and PIVKA-II. AFP-L3 and PIVKA-II as an effective tumor marker for hepatocellular carcinoma(HCC). Despite the extensive application of PIVKA-II in some hospitals from Vietnam, the diagnostic efficiency including sensitivity, specificity, positive predictive value and negative predictive value still needs more clinical data to evaluate. The research purposes list as follows：1. Determination of changes in AFP-L3 and PIVKA II for HCC.2. Investigating the diagnostic value of AFP-L3 and PIVKA II for HCC. This study is performed at Hanoi Medical University Hospital. Participants including patients with HCC and hepatic hemangioma. 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, AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.The diagnosis of HCC was based on HCC criteria of Ministry of Public Health of Vietnam. All HCC diagnoses were confirmed at the time of analysis. Stages of tumor is evaluated by Barcelana classification. 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 performance characteristic of PIVKA-II,AFP,AFP-L3 measurement.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: OTHER

Study Groups

Hepatocellular carcinoma patients

Serum samples are collected before liver resection.

AFP-L3 and PIVKA-II in HCC

Intervention Type: DIAGNOSTIC_TEST

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

Imaging: CT or MRI

Hepatic hemangioma patients

AFP-L3 and PIVKA-II in HCC

Intervention Type: DIAGNOSTIC_TEST

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

Imaging: CT or MRI

Interventions

AFP-L3 and PIVKA-II in HCC

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

Imaging: CT or MRI

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 85
• Receiving no treatment before diagnosis
• Establishing Diagnosis according to thecriteria of Ministry of Public Health of Vietnam 2012.

Exclusion Criteria

• Clinical data missing
• Laboratory tests information missing
• Serum samples doesn't qualified
• Obstructive jaundice patients
• Medical history of taking warfarin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bach Mai Hospital

OTHER

Sponsor Role: collaborator

Hanoi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bui My Hanh

Director, Science Research and International Cooperation Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanoi Medical University

Hanoi, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Facility Contacts

Bui My Hanh, MD

Role: primary

buimyhanh@hmu.edu.vn

+84983070973

Nguyen Hoang Hiep, BSc

Role: backup

hiepnhh1993@gmail.com

+84964163292

Other Identifiers

HMU16222

Identifier Type: -

Identifier Source: org_study_id