Torque Teno Virus: A Biomarker of Immunosuppression

Study Overview
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Brief Summary
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To seek an association between Torque Teno Virus DNA titres resulting from under or over-immunosuppression in a kidney allograft recipient, Graft rejection, both cell-mediated rejection and antibody-mediated rejection, donor-specific antibodies (DSA), the incidence of BK viraemia and BK nephropathy, CMV infection or diseases and PCP infection and the number of circulating NK, B and T lymphocyte subtypes.

Detailed Description
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Balancing the adverse effects of over-immunosuppression such as infection and malignancy, to the risk of rejection, remains the central challenge for day-to-day clinical practice in transplantation. A quantitative measure of immunocompetence remains elusive, and in absence of such markers, immunosuppression drug concentrations and clinical events, such as organ rejection, infection, malignancy etc. are used as surrogate markers of immunocompetence to guide therapy. As demonstrated in several studies, the Torque teno virus is widespread amongst the general population. In theory, if one suppresses the immune system, these viruses should multiply, resulting in a higher DNA level which can be detected by a simple blood test. Hence, the DNA level could be used as an indicator for the level of immunosuppression, along with the available blood tests to measure the level of toxicity of the said drugs. In our research to be done at the Royal London Hospital, we aim to elucidate that the Torque teno virus is widely prevalent in an ethnically diverse East London kidney transplant recipient population by conducting the viral PCR on blood samples already collected during their routine clinic visits. The population will include all kidney transplant recipients in a two-year period. We will measure the correlation between the TTV DNA level and drug concentrations of the immunosuppressive medications which will tell us how the DNA levels are affected by different drug concentrations. We will then measure the correlation between the TTV DNA levels, and the common adverse outcomes experienced by the transplant recipients, namely, patient death, loss of transplant organs, transplant rejection, rates of infection, and cancers in transplant patients by collecting data from patient records. These tests will help us understand whether the Torque teno virus DNA levels can be used as a marker of immunosuppression in the general population in the UK.

Official Title
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Torque Teno Virus: A Biomarker of Immunosuppression in Kidney Transplantation, an Observational Single Centre Study

Conditions
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Renal Transplant Rejection, Immunosuppression, Renal Transplant Failure, Renal Transplant Infection

Intervention / Treatment
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* Other: None Observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consenting renal transplant recipients in the study period will be included in the study Exclusion Criteria: no exclusion criteria.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal transplant recipients<br>All incident renal transplant recipients after the commencement of the study | Other: None Observational study<br>* Non interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy proven graft rejection |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal transplant, immunosuppression, Torque teno virus