Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients

NCT ID: NCT05852964

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-03

Study Completion Date

2023-12-25

Brief Summary

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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

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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.

Conditions

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Liver Transplant; Complications Infections Gene Amplification Immune Response

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Healthy 13 female 14 male subjects

Molecular Immunology , gene expressions

Intervention Type GENETIC

Expression levels of inflammatory and anti-inflammatory genes

Transplantation Patients

10 female, 17 male subjects

Molecular Immunology , gene expressions

Intervention Type GENETIC

Expression levels of inflammatory and anti-inflammatory genes

Interventions

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Molecular Immunology , gene expressions

Expression levels of inflammatory and anti-inflammatory genes

Intervention Type GENETIC

Other Intervention Names

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Diagnostic test

Eligibility Criteria

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Inclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anadolu University

OTHER

Sponsor Role collaborator

Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Başak KAYHAN, Ph.D. Prof.

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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İnönü University

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 16018884 (View on PubMed)

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.

Reference Type RESULT
PMID: 22006860 (View on PubMed)

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.

Reference Type RESULT
PMID: 17097977 (View on PubMed)

Other Identifiers

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2021/24

Identifier Type: -

Identifier Source: org_study_id

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