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

NCT03602703 | Completed

• 1 other identifier: 17300211
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Drug-Induced Liver Injury

Keywords

Direct acting antiviral drugs immune responses

Outcome Measures

Primary Outcomes (1)

• Pattern of immunity in patients with de novo HCC develped after treatment with DAAs

  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

Study Arms (4)

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

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

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

Control group

Healthy subjects

Interventions

Flow cytometry and Western Blot analysis DIAGNOSTIC_TEST

Diagnostic tests

Liver cirrhosis with HCC; Liver cirrhosis without HCC; chronic HCV

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 7771, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Haidi Ramadan, Lecturer

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 27, 2018
• Study Start: July 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 9, 2020

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)