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

Assiut University

Status: Completed

Conditions: Drug-Induced Liver Injury

Treatments: Diagnostic Test: Flow cytometry and Western Blot analysis

Study type: Observational

Funder types: Other

Identifiers

NCT03602703

17300211

Details and patient eligibility

About

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

Full 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Blood sample from all patients will be withdrawn.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.

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 4 patient groups

chronic HCV

Description:

chronic HCV either treated or not with DAAs.Flow cytometry and Western Blot analysis for each subgroup

Treatment:

Diagnostic Test: Flow cytometry and Western Blot analysis

Liver cirrhosis without HCC

Description:

Liver cirrhosis without HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup

Treatment:

Diagnostic Test: Flow cytometry and Western Blot analysis

Liver cirrhosis with HCC

Description:

Liver cirrhosis with HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup

Treatment:

Diagnostic Test: Flow cytometry and Western Blot analysis

Control group

Description:

Healthy subjects