Clinical trial NCT05852964: Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients
Official title: Investigation of Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients Before and After the Operation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant; Complications
Infections
Gene Amplification
Immune Response
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: Anadolu University
First posted: 2023-05-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria: Healthy volunteers without acute or chronic diseases

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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.

Primary outcomes:
measure: Biochemical parameters
timeFrame: 1st month
measure: Gene expression parameters before surgery
timeFrame: 1st month
Secondary outcomes:
measure: Gene Expression parameters after surgery
timeFrame: 2nd-3rd months
measure: Gene Expression parameters after surgery
timeFrame: 4-6th months
Other outcomes:
measure: Microbiological analysis
timeFrame: 1st-6th months
Locations:
city: Malatya
country: Turkey
facility: İnönü University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.