Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 11:54 PM
Study NCT ID:
NCT03602703
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2018-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Detection of Immune Cell Responses in Chronic HCV Patients Developing Hepatocellular Carcinoma After Treatment With Direct Acting Antiviral Drugs (DAAs)
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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Blood sample from all patients will be withdrawn.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.
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Blood sample from all patients will be withdrawn.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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: