Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients

NCT05852964 | Unknown

• 1 other identifier: 2021/24
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

In our study, some inflammatory Interleukin-2 , Interleukin-6, Interferon-γ, Tumor Necrosis Factor-α and anti-inflammatory Interleukin-4 and Interleukin-10 cytokine genes expressions and Triggering Receptor Expressed On Myeloid Cells- 1, which contributes to the pathology of acute and chronic inflammatory diseases; Human Leukocyte Antigen-G5, which suppresses the immune response; the expression levels of transcription factor Forkhead box-P3 expressed in regulatory T-lymphocytes and Cluster of Differentiation (CD)14 genes, which are thought to be biomarkers in various infectious diseases and expressed in monocytes, will be measured from peripheral blood samples obtained from liver transplant patients before, 1 month and 6 months after the operation. In addition, the classical liver markers Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Platelet Count (PLT), Alpha Feto Protein (AFP), Direct Bilirubin (Bilirubin D), Total Bilirubin (Bilirubin T) and C- Levels of biochemical parameters such as Reactive Protein (CRP) will be measured. In the light of the data to be obtained, it is aimed to find biomarkers with high predictive value for rejection and infection after liver transplantation.

Conditions

Liver Transplant; Complications; Infections; Gene Amplification; Immune Response

Outcome Measures

Primary Outcomes (2)

• Biochemical parameters

  ALT, AST, PLT, AFP, Bilirubin Direct, Bilirubin Total, CRP levels of all subject in control and Transplantation groups before surgery.

  1st month

• Gene expression parameters before surgery

  Expression levels of Interleukin-2, Interleukin-6, Interferon-gamma, Tumor Necrosis Factor-alpha, Interleukin-4, Interleukin-10, Triggering Receptors Expressed on Myeloid Cells-1, Human Leukocyte Antigen-G5, Forkhead box p3 and Cluster of Differentiation (CD)14 in peripheral blood samples

  1st month

Secondary Outcomes (2)

• Gene Expression parameters after surgery

  2nd-3rd months

• Gene Expression parameters after surgery

  4-6th months

Other Outcomes (1)

• Microbiological analysis

  1st-6th months

Study Arms (2)

Control

Healthy 13 female 14 male subjects

Genetic: Molecular Immunology , gene expressions

Transplantation Patients

10 female, 17 male subjects

Genetic: Molecular Immunology , gene expressions

Interventions

Molecular Immunology , gene expressions GENETIC

Expression levels of inflammatory and anti-inflammatory genes

Also known as: Diagnostic test

Control; Transplantation Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

It includes patients who do not disrupt their pre- and post-transplant controls and treatment process, among patients with suitable liver disease, among those whose transplantation decision has been taken in accordance with the protocols of İnönü University Liver Transplantation Institute.

Sponsors & Collaborators

• Inonu University: lead
• Anadolu University: collaborator

Study Sites (1)

İnönü University

Malatya, 44100, Turkey (Türkiye)

Location

Related Publications (3)

• Carvalho-Gaspar M, Billing JS, Spriewald BM, Wood KJ. Chemokine gene expression during allograft rejection: comparison of two quantitative PCR techniques. J Immunol Methods. 2005 Jun;301(1-2):41-52. doi: 10.1016/j.jim.2005.03.003. Epub 2005 Apr 1.

  PMID: 16018884 BACKGROUND

• Friedman BH, Wolf JH, Wang L, Putt ME, Shaked A, Christie JD, Hancock WW, Olthoff KM. Serum cytokine profiles associated with early allograft dysfunction in patients undergoing liver transplantation. Liver Transpl. 2012 Feb;18(2):166-76. doi: 10.1002/lt.22451.

  PMID: 22006860 RESULT

• Hassan L, Bueno P, Ferron-Celma I, Ramia JM, Garrote D, Muffak K, Barrera L, Villar JM, Garcia-Navarro A, Mansilla A, Gomez-Bravo MA, Bernardos A, Ferron JA. Early postoperative response of cytokines in liver transplant recipients. Transplant Proc. 2006 Oct;38(8):2488-91. doi: 10.1016/j.transproceed.2006.08.054.

  PMID: 17097977 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Infections

Interventions

Gene Expression

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: May 3, 2023
• Primary Completion: December 3, 2023
• Study Completion: December 25, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: For 2 years

Locations

TU (1)