Liver Transplant; ComplicationsNCT05852964
Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients
An observational study of Liver Transplant; Complications and Infections, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant; Complications, Infections, Gene Amplification
- What is being tested?
- Molecular Immunology , gene expressions
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2023to 25 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients Before and After the Operation
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.
Read the 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.
- Being tested
- Molecular Immunology , gene expressions
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Immunology , gene expressionsGenetic
Also called Diagnostic test
Expression levels of inflammatory and anti-inflammatory genes
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy 13 female 14 male subjects Receives: Genetic: Molecular Immunology , gene expressions | |
| Transplantation Patients | 10 female, 17 male subjects Receives: Genetic: Molecular Immunology , gene expressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameters
ALT, AST, PLT, AFP, Bilirubin Direct, Bilirubin Total, CRP levels of all subject in control and Transplantation groups before surgery.
Measured: 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
Measured: 1st month
Secondary outcomes (2)
Gene Expression parameters after 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
Measured: 2nd-3rd months
Gene Expression parameters after 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
Measured: 4-6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start3 May 2023
- Primary completion3 Dec 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Anadolu University
- Responsible party
- Principal investigator, Başak KAYHAN, Ph.D. Prof., Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852964
- Sponsor's protocol ID
- 2021/24
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, statistical analysis plans can be shared
Publications
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.
PubMed 16018884Friedman 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.
PubMed 22006860Hassan 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.
PubMed 17097977
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients Before and After the Operation
- ClinicalTrials.gov ID
- NCT05852964
- Acronym / sponsor ID
- 2021/24
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- Anadolu University
- Study start
- 3 May 2023 (actual)
- Primary completion
- 3 Dec 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Genetic: Molecular Immunology , gene expressionsHealthy 13 female 14 male subjects |
| Transplantation Patients | – | Genetic: Molecular Immunology , gene expressions10 female, 17 male subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular Immunology , gene expressionsAlso: Diagnostic testExpression levels of inflammatory and anti-inflammatory genes | Genetic | Control, Transplantation Patients |
Primary outcome
Biochemical parameters
Time frame: 1st month
ALT, AST, PLT, AFP, Bilirubin Direct, Bilirubin Total, CRP levels of all subject in control and Transplantation groups before surgery.
Gene expression parameters before surgery
Time frame: 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
2 secondary outcomes
Gene Expression parameters after surgery
Time frame: 2nd-3rd months
Gene Expression parameters after surgery
Time frame: 4-6th months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 16018884Carvalho-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.
- Results publication: PubMed 22006860Friedman 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.
- Results publication: PubMed 17097977Hassan 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.
- Individual participant dataSharing planned: Yes. Study protocol, statistical analysis plans can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications and Infections, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical parameters (time frame: 1st month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05852964, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.