Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients

Sponsor
Inonu University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05852964
Collaborator
Anadolu University (Other)
54
1
7.8
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Molecular Immunology , gene expressions

Detailed Description

Liver transplantation is the transplantation of the liver, which is completely or partially removed by surgical intervention, from a living or brain-dead cadaver to the recipient. Today, organ transplantation procedures are carried out successfully in many centers in our country.Liver transplantation has become the most effective treatment method for acute and chronic liver failure due to different reasons.The life expectancy of individuals with advanced liver disease, which was limited to months before liver transplantation, was extended with liver transplantation and the quality of life was improved with this treatment method. However, since most of the organ transplants are made from genetically different donors, tissue compatibility between the donor and the recipient remains a problem.Therefore, the recipient's immune response to donor graft antigens should be considered.

In recent years, the application of advanced surgery and new immunosuppressive approaches has made it possible to successfully transplant almost any vital organ or tissue. However, due to both infection and genetic factors, an immune response to the donor organ may develop and cause organ rejection. At this point, we think that early diagnosis and discovery of immune response parameters that distinguish infection from rejection may be important.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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
54 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Investigation of Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients Before and After the Operation
Actual Study Start Date :
May 3, 2023
Anticipated Primary Completion Date :
Dec 3, 2023
Anticipated Study Completion Date :
Dec 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Control

Healthy 13 female 14 male subjects

Genetic: Molecular Immunology , gene expressions
Expression levels of inflammatory and anti-inflammatory genes
Other Names:
  • Diagnostic test
  • Transplantation Patients

    10 female, 17 male subjects

    Genetic: Molecular Immunology , gene expressions
    Expression levels of inflammatory and anti-inflammatory genes
    Other Names:
  • Diagnostic test
  • Outcome Measures

    Primary Outcome Measures

    1. Biochemical parameters [1st month]

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

    2. Gene expression parameters before surgery [1st month]

      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

    Secondary Outcome Measures

    1. Gene Expression parameters after surgery [2nd-3rd months]

      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

    2. Gene Expression parameters after surgery [4-6th months]

      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

    Other Outcome Measures

    1. Microbiological analysis [1st-6th months]

      Culture analysis in urine and blood samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria: Healthy volunteers without acute or chronic diseases

    -

    Exclusion Criteria: without acute or chronic bacterial and viral infections; Anti-Hepatitis-C (+), HBsAg (+), Anti-HIV (+), renal failure, neutropenia, using immune supressor medications, autoimmunity (+), acute or chronic pancreatitis, being treated with burns, pregnant, using steroid medications, diabetic patients, any malignancy has been identified and treated.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 İnönü University Malatya Turkey 44100

    Sponsors and Collaborators

    • Inonu University
    • Anadolu University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Başak KAYHAN, Ph.D. Prof., Prof.Dr., Inonu University
    ClinicalTrials.gov Identifier:
    NCT05852964
    Other Study ID Numbers:
    • 2021/24
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 10, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 10, 2023