Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs

April 7, 2020 updated by: Haidi Karam, Assiut University

Detection of Immune Cell Responses in Chronic HCV Patients Developing Hepatocellular Carcinoma After Treatment With Direct Acting Antiviral Drugs (DAAs)

Case control Study to assess the difference of immune cell responses between patients with chronic HCV- related liver cirrhosis who develop HCC after treatment with DAAs and those who do not develop HCC

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical and laboratory assessment with measurement of Child-Pugh and MELD scores to assess the severity of liver disease and measurement of alpha fetoprotein level for HCC cases will be done.

Radiological assessment using abdominal ultrasound and triphasic CT will be done to determine the extent of the HCC and staging.

Blood sample from all patients will be withdrawn. Plasma will be isolated and stored at - 20C and further analysis for a panel of cytokines, caspases and growth factors using ELISA will be monitored.

Peripheral blood mononuclear cells (PBMCs) will be isolated using ficoll gradient method and will then be stored at -80C.

B and T cell proliferation in response to specific antigens will also be investigated using CFSE staining assay followed by flow cytometry analysis for CD4, CD8 and PD-1.

Cell cycle analysis and apoptosis will be detected using Annexin V/PI staining method and flow cytometry analysis. The phosphorylation and activation of cytoplasmic proteins will be tested using Western blot analysis.

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 7771
        • Assiut University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cases recruited divided into three groups .Each group either treated or not with DAAs

Description

Inclusion Criteria:

  • Patients with HCC on top of HCV related liver cirrhosis either received treatment or not
  • Patients without HCC either received treatment or not .
  • Patients with chronic HCV as a control group either received treatment or not.

Exclusion Criteria:

  • Patients with HCC who received any interventional treatment as alcohol injection, radiofrequency , TACE..etc
  • Patients with recurrent HCC after curative treatment.

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
Control group
Healthy subjects
chronic HCV
chronic HCV either treated or not with DAAs.Flow cytometry and Western Blot analysis for each subgroup
Diagnostic test: Flow cytometry and Western Blot analysis
Diagnostic tests
Liver cirrhosis without HCC
Liver cirrhosis without HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup
Diagnostic test: Flow cytometry and Western Blot analysis
Diagnostic tests
Liver cirrhosis with HCC
Liver cirrhosis with HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup
Diagnostic test: Flow cytometry and Western Blot analysis
Diagnostic tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of immunity in patients with de novo HCC develped after treatment with DAAs
Time Frame: Two months
Difference of B and T cells immune responses after treatment with DAAs between those who develop HCC and those who do not develop HCC
Two months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Haidi Ramadan, Lecturer, lecturer

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)

July 1, 2018

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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