Annexin A2 as a Novel Diagnostic Marker in Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Annexin A2 as a Novel Diagnostic Marker for Hepatocellular Carcinoma in Egyptian Patients

Conditions
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Hepatocellular Carcinoma (HCC)

Intervention / Treatment
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* Procedure: blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for HCC cases: Confirmed diagnosis of HCC according to the European association of study of liver diseases [13]. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum Annexin A2 in patients with hepatocellular carcinoma, chronic liver disease and healthy subjects | 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). | 1 month |