Annexin A2 as a Novel Diagnostic Marker in Hepatocellular Carcinoma

Ain Shams University

Status: Completed

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Procedure: blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT02541149

Annexin A2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Group 1:

Description:

Fifty patients with early stage hepatocellular carcinoma(BCLC stage A)

Treatment:

Procedure: blood sample

Group 2

Description:

Twenty five patients with chronic liver disease diagnosed based on clinical, laboratory, and ultrasonographic investigations;

Treatment:

Procedure: blood sample

Group 3

Description:

Control Group: Fifteen healthy, age and sex-matched subjects with seronegative hepatitis viral markers

Treatment:

Procedure: blood sample