Hepatocellular Carcinoma (HCC)NCT02541149
Annexin A2 as a Novel Diagnostic Marker in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma (HCC), run by Ain Shams University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2015
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult Egyptian patients attending outpatient clinic for HCC , Ain Shams University Hospitals, Cairo Egypt (Group 1\&2)
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Evaluation of Annexin A2 as a Novel Diagnostic Marker for Hepatocellular Carcinoma in Egyptian Patients
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).
Read the 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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- blood sample
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | Fifty patients with early stage hepatocellular carcinoma(BCLC stage A) Receives: Procedure: blood sample | |
| Group 2 | Twenty five patients with chronic liver disease diagnosed based on clinical, laboratory, and ultrasonographic investigations; Receives: Procedure: blood sample | |
| Group 3 | Control Group: Fifteen healthy, age and sex-matched subjects with seronegative hepatitis viral markers Receives: Procedure: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541149
- Sponsor's protocol ID
- Annexin A2
- Status last verified
- Sep 2015
- First submitted
- 1 Sep 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No