Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transplant patients.
- Who it may be relevant to
- Registry conditions: Renal-urinary Impairment, Graft Rejection, Infection Episodes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time. The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.
Interventions
- Genetic Transplant patients
Study the specific immunity against Polyomavirus
Primary outcome measures
- BKV viral load in urine (viruria) and in plasma (viremia) [Time frame: 3 years]
Secondary outcome measures (1)
- Quantification of anti-BKV neutralizing antibodies [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Lung transplant recipients in Strasbourg University Hospital between 30 June 2018 and 31 December 2022
- Male or female patients, age over 18 years
- Patient having provided informed written consent to take part in the study
- Patient affiliated to Social Security
Exclusion criteria
- Patient deprived of liberty, by judicial or administrative decision
- Patient under legal guardianship
- Impossibility to give complete information about this study to the patient
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Les Hôpitaux Universitaires de Strasbourg — Strasbourg
Identifiers
NCT: NCT04164576 · 7547