Golgi Protein for HCC Diagnosis

January 31, 2017 updated by: Shereen Abou Bakr Saleh, Ain Shams University

Golgi Protein 73 for Diagnosis of HCC in Egyptian Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Golgi protein correlated with presence of HCC
Time Frame: within one year
within one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2014

Primary Completion (Actual)

December 30, 2015

Study Completion (Actual)

December 30, 2015

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 914 (Northumbria University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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