Annexin A2 as a Novel Diagnostic Marker in Hepatocellular Carcinoma

Completed

• Conditions: Hepatocellular Carcinoma (HCC)
• Interventions: Procedure: blood sample

• Registration Number: NCT02541149
• Lead Sponsor: Ain Shams University

Brief Summary

This study aimed to investigate the clinical utility of Annexin A2 serum level as a novel diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha fetoprotein the current marker ofhepatocellular carcinoma (HCC).

Detailed Description

This study was carried out in HCC clinic , Ain Shams University Hospitals, Cairo; Egypt and included :Group 1: Fifty patients with early stage hepatocellular carcinoma(BCLC stage A); Group 2:Twenty five patients with chronic liver disease diagnosed based on clinical, laboratory, and ultrasonographic investigations; Control Group: Fifteen healthy, age and sex-matched subjects with seronegative hepatitis viral markers .All groups were subjected to thorough history taking, full clinical examination, and laboratory investigations including viral hepatitis markers: HBsAg and HCV antibodies using ELISA technique and HCV RNA using real time PCR for HCV antibody positive patients, AFP by electrochemiluminescence and Annexin A2 estimation using ELISA technique.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-09
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-03
• Last Update Submitted: 2015-09-03
• Study First Posted: 2015-09-04
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Inclusion criteria for HCC cases:

  1. Confirmed diagnosis of HCC according to the European association of study of liver diseases [13].
  2. Early stage HCC (Stage A), using the Barcelona Clinic Liver Cancer (BCLC) staging system, (single or 3 nodules < 3cm PS 0) For all participants:.

• Informed consent from all participants before enrollment in the study.

Exclusion Criteria

• For HCC patients:

  1-Imtermediate or advanced stage HCC as defined by BCLC 2. Major vascular tumor invasion or metastasis confirmed by radiological imaging studies.

  3. Patients with other suspected solid malignancies or metastatic liver tumors, 4. Other types of chronic liver diseases (CLD) such as autoimmune hepatitis and primary biliary cirrhosis.

• For all participants:

  • Refusal to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1:	blood sample	Fifty patients with early stage hepatocellular carcinoma(BCLC stage A)
Group 2	blood sample	Twenty five patients with chronic liver disease diagnosed based on clinical, laboratory, and ultrasonographic investigations;
Group 3	blood sample	Control Group: Fifteen healthy, age and sex-matched subjects with seronegative hepatitis viral markers

Primary Outcome Measures

Name	Time	Method
serum Annexin A2 in patients with hepatocellular carcinoma, chronic liver disease and healthy subjects	1 month	to determine the clinical utility of Annexin A2 serum level as a novel diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha fetoprotein the current marker of (HCC).