T Regulatory Cells in Hepatitis c Infected Patients

NCT03186235 | Completed

• 1 other identifier: Esraa
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic hepatitis C infection is a global worldwide health problem with an increasing burden year-by-year, particularly in areas with a high endemicity like Egypt . The World Health Organization estimates that approximately 200 million people worldwide are infected with hepatitis c virus. In Egypt, it was estimated that 15 % of Egyptians have serologic evidence of hepatitis C viral infection .

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• frequency of T regulatory cells in all 6 groups using flow cytometry

  frequency of T regulatory cells will be estimated by flow cytometry in all 6 groups

  An average 1 year

Study Arms (5)

Group I : 18 healthy controls

Two milliliter of heparinized whole blood samples will be used for the Flow cytometry analysis to quantify percentages of circulating regulatory T cells in human peripheral blood in chronic hepatitis C patients in comparison with that of controls by four-colour flow cytometry analysis using a set of fluorochrome-labeled monoclonal antibodies against regulatory T cell surface markers and estimation of the level of IL35 by ElISA.

Other: Flow cytometry

group II : 16 Hepatitis C infected patients (naïve)

Two milliliter of heparinized whole blood samples will be used for the Flow cytometry analysis to quantify percentages of circulating regulatory T cells in human peripheral blood in chronic hepatitis C patients in comparison with that of controls by four-colour flow cytometry analysis using a set of fluorochrome-labeled monoclonal antibodies against regulatory T cell surface markers and estimation of the level of IL35 by ElISA.

Other: Flow cytometry

group III:18 HCV-infected patients complicated with cirrhosis

Two milliliter of heparinized whole blood samples will be used for the Flow cytometry analysis to quantify percentages of circulating regulatory T cells in human peripheral blood in chronic hepatitis C patients in comparison with that of controls by four-colour flow cytometry analysis using a set of fluorochrome-labeled monoclonal antibodies against regulatory T cell surface markers and estimation of the level of IL35 by ElISA.

Other: Flow cytometry

group IV: 18 HCV-infected patients with Hepatocellular cancer

Two milliliter of heparinized whole blood samples will be used for the Flow cytometry analysis to quantify percentages of circulating regulatory T cells in human peripheral blood in chronic hepatitis C patients in comparison with that of controls by four-colour flow cytometry analysis using a set of fluorochrome-labeled monoclonal antibodies against regulatory T cell surface markers and estimation of the level of IL35 by ElISA.

Other: Flow cytometry

Group V:18 patients with sustained viral response (SVR).

Two milliliter of heparinized whole blood samples will be used for the Flow cytometry analysis to quantify percentages of circulating regulatory T cells in human peripheral blood in chronic hepatitis C patients in comparison with that of controls by four-colour flow cytometry analysis using a set of fluorochrome-labeled monoclonal antibodies against regulatory T cell surface markers and estimation of the level of IL35 by ElISA.

Other: Flow cytometry

Interventions

Flow cytometry OTHER

Isolation of T regulatory cells from blood

Group I : 18 healthy controls; Group V:18 patients with sustained viral response (SVR).; group II : 16 Hepatitis C infected patients (naïve); group III:18 HCV-infected patients complicated with cirrhosis; group IV: 18 HCV-infected patients with Hepatocellular cancer

Eligibility Criteria

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

Study Population

. All participants were recruited from Assiut Liver Institute for Treatment of Hepatitis C Virus and Assiut University Hospitals outpatient clinics, Assiut, Egypt. Healthy donors will be attending blood bank of Assiut University Hospital during the study period. They will be negative for known serologic markers of hepatitis (B \& C) including hepatitis B surface antigen and antibodies to Hepatitis C virus

You may qualify if:

• positive for hepatitis c viral antibodies by Enzyme Linked Immuno Sorbent Assay and by hepatitis c viral Ribo Nucleic Acid Real time Polymerase Chain Reaction

You may not qualify if:

• are pregnancy, history of Schistosoma infection, inflammatory bowel diseases or suspected inflammatory bowel diseases , autoimmune diseases including rheumatoid arthritis, and any patients on systemic immunomodulators

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (8)

• Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.

  PMID: 11439948 BACKGROUND

• Klenerman P, Thimme R. T cell responses in hepatitis C: the good, the bad and the unconventional. Gut. 2012 Aug;61(8):1226-34. doi: 10.1136/gutjnl-2011-300620. Epub 2011 Aug 28.

  PMID: 21873736 BACKGROUND

• Bowen DG, Walker CM. Adaptive immune responses in acute and chronic hepatitis C virus infection. Nature. 2005 Aug 18;436(7053):946-52. doi: 10.1038/nature04079.

  PMID: 16107834 BACKGROUND

• Hartling HJ, Gaardbo JC, Ronit A, Knudsen LS, Ullum H, Vainer B, Clausen MR, Skogstrand K, Gerstoft J, Nielsen SD. CD4(+) and CD8(+) regulatory T cells (Tregs) are elevated and display an active phenotype in patients with chronic HCV mono-infection and HIV/HCV co-infection. Scand J Immunol. 2012 Sep;76(3):294-305. doi: 10.1111/j.1365-3083.2012.02725.x.

  PMID: 22671952 BACKGROUND

• Sturm N, Thelu MA, Camous X, Dimitrov G, Ramzan M, Dufeu-Duchesne T, Bonorino P, Guillermet C, Brambilla E, Arvers P, Pernollet M, Leroy V, Zarski JP, Marche PN, Jouvin-Marche E. Characterization and role of intra-hepatic regulatory T cells in chronic hepatitis C pathogenesis. J Hepatol. 2010 Jul;53(1):25-35. doi: 10.1016/j.jhep.2010.02.024. Epub 2010 Apr 20.

  PMID: 20452085 BACKGROUND

• Sakaguchi S, Yamaguchi T, Nomura T, Ono M. Regulatory T cells and immune tolerance. Cell. 2008 May 30;133(5):775-87. doi: 10.1016/j.cell.2008.05.009.

  PMID: 18510923 BACKGROUND

• Magg T, Mannert J, Ellwart JW, Schmid I, Albert MH. Subcellular localization of FOXP3 in human regulatory and nonregulatory T cells. Eur J Immunol. 2012 Jun;42(6):1627-38. doi: 10.1002/eji.201141838.

  PMID: 22678915 BACKGROUND

• Adams DH, Eksteen B, Curbishley SM. Immunology of the gut and liver: a love/hate relationship. Gut. 2008 Jun;57(6):838-48. doi: 10.1136/gut.2007.122168. Epub 2008 Jan 18. No abstract available.

  PMID: 18203807 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

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 Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: June 14, 2017
• Study Start: July 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)