Annexin A2 as a Novel Diagnostic Marker in Hepatocellular Carcinoma

NCT02541149 | Completed

• 1 other identifier: Annexin A2
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 1:

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

Procedure: blood sample

Group 2

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

Procedure: blood sample

Group 3

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

Procedure: blood sample

Interventions

blood sample PROCEDURE

Group 1:; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Egyptian patients attending outpatient clinic for HCC , Ain Shams University Hospitals, Cairo Egypt (Group 1\&2)

You may qualify if:

• 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.

You may not qualify if:

• For HCC patients:
• Imtermediate or advanced stage HCC as defined by BCLC 2. Major vascular tumor invasion or metastasis confirmed by radiological imaging studies.
• \. 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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of tropical medicine , Ain Shams university

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 4, 2015
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-09