Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients

NCT ID: NCT04164576

Last Updated: 2019-11-15

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

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-31

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal-urinary Impairment Graft Rejection Infection Episodes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transplant patients

Study the specific immunity against Polyomavirus

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Les Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Facility Contacts

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Samira FAFI-KREMER

Role: primary

+33 369551438

Other Identifiers

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7547

Identifier Type: -

Identifier Source: org_study_id

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