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Completed

NCT Number: NCT03602703

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

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

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Key information

Conditions

Drug-Induced Liver Injury Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Liver Diseases Poisoning

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University

Asyut, 7771, Egypt

About this study

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Blood sample from all patients will be withdrawn.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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flow cytometry and Western Blot analysis

Diagnostic Test

Diagnostic tests

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2018
Registry last updated
Apr 9, 2020

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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