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

Completed

• Conditions: Drug-Induced Liver Injury
• Interventions: Diagnostic Test: Flow cytometry and Western Blot analysis

• Registration Number: NCT03602703
• Lead Sponsor: Assiut University

Brief Summary

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

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Blood sample from all patients will be withdrawn.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 Timeline

• Status Verified: 2018-07
• Study Start: 2018-07-01
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-27
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver cirrhosis without HCC	Flow cytometry and Western Blot analysis	Liver cirrhosis without HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup
Liver cirrhosis with HCC	Flow cytometry and Western Blot analysis	Liver cirrhosis with HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup
chronic HCV	Flow cytometry and Western Blot analysis	chronic HCV either treated or not with DAAs.Flow cytometry and Western Blot analysis for each subgroup

Primary Outcome Measures

Name	Time	Method
Pattern of immunity in patients with de novo HCC develped after treatment with DAAs	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

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt