Torque Teno Virus: A Biomarker of Immunosuppression

Sponsor
Queen Mary University of London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05756036
Collaborator
(none)
400
1
30.5
13.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: None Observational study

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Torque Teno Virus: A Biomarker of Immunosuppression in Kidney Transplantation, an Observational Single Centre Study
Actual Study Start Date :
Feb 15, 2022
Anticipated Primary Completion Date :
Feb 14, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Renal transplant recipients

All incident renal transplant recipients after the commencement of the study

Other: None Observational study
Non interventional study

Outcome Measures

Primary Outcome Measures

  1. Biopsy proven graft rejection [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All consenting renal transplant recipients in the study period will be included in the study
Exclusion Criteria:
  • no exclusion criteria.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal London Hospital London United Kingdom SW4 8FA

Sponsors and Collaborators

  • Queen Mary University of London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT05756036
Other Study ID Numbers:
  • 291391
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Queen Mary University of London

Study Results

No Results Posted as of Mar 6, 2023