NCT Number: NCT02541149
Annexin A2 as a Novel Diagnostic Marker in Hepatocellular Carcinoma
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).
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Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
- 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
Treatment and study plan
Primary outcomes
-
serum Annexin A2 in patients with hepatocellular carcinoma, chronic liver disease and healthy subjects
Time frame: 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).
Sponsors and collaborators
Lead sponsor
Ain Shams University
Other
Registry information
Official study title
Evaluation of Annexin A2 as a Novel Diagnostic Marker for Hepatocellular Carcinoma in Egyptian Patients
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Sep 4, 2015
- Registry last updated
- Sep 4, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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