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Golgi Protein for HCC Diagnosis

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ClinicalTrials.gov Identifier: NCT03039322
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Shereen Abou Bakr Saleh, Ain Shams University

Brief Summary:
This case-control study was conducted on 90 patients who were equally divided into two groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured using ELISA technique

Condition or disease Intervention/treatment
Screening for Hepatocellular Carcinoma Diagnostic Test: Serum Golgi Protein 73

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Golgi Protein 73 for Diagnosis of HCC in Egyptian Patients
Actual Study Start Date : December 22, 2014
Actual Primary Completion Date : December 30, 2015
Actual Study Completion Date : December 30, 2015

Group/Cohort Intervention/treatment
HCC Diagnostic Test: Serum Golgi Protein 73
Serum test

liver cirrhosis No HCC Diagnostic Test: Serum Golgi Protein 73
Serum test




Primary Outcome Measures :
  1. Golgi protein correlated with presence of HCC [ Time Frame: within one year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Group I: Included 45 patients with liver cirrhosis due to HCV infection. Liver cirrhosis was diagnosed clinically, laboratory, and radiologically. Chronic HCV infection was diagnosed by positive HCV antibody and positive quantitative HCV PCR.

Group II: Included 45 patients with Hepatocellular carcinoma (HCC) on top of HCV cirrhosis diagnosed by two imaging modalities, abdominal ultrasound and the characteristic arterial enhancement and venous washout in Tri-phasic CT abdomen.

Criteria

Inclusion Criteria:

  • patients were older than 18 years.

Exclusion Criteria:

  • patients with hepatic focal lesions not due to HCC such as Hemangioma, Hepatic cyst, and liver metastases; patients infected with HIV; patients with any autoimmune disease; or patients with metastatic disease.
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Responsible Party: Shereen Abou Bakr Saleh, Assisstant Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03039322    
Other Study ID Numbers: 914
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases