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

NCT ID: NCT03602703

Last Updated: 2020-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-09-01

Brief Summary

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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

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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Blood sample from all patients will be withdrawn.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.

Conditions

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Drug-Induced Liver Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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chronic HCV

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

Flow cytometry and Western Blot analysis

Intervention Type DIAGNOSTIC_TEST

Diagnostic tests

Liver cirrhosis without HCC

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

Flow cytometry and Western Blot analysis

Intervention Type DIAGNOSTIC_TEST

Diagnostic tests

Liver cirrhosis with HCC

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

Flow cytometry and Western Blot analysis

Intervention Type DIAGNOSTIC_TEST

Diagnostic tests

Control group

Healthy subjects

No interventions assigned to this group

Interventions

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Flow cytometry and Western Blot analysis

Diagnostic tests

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Haidi Karam

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haidi Ramadan, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17300211

Identifier Type: -

Identifier Source: org_study_id

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