Casting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation
NCT ID: NCT05701228
Last Updated: 2024-12-24
Study Results
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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RECRUITING
525 participants
OBSERVATIONAL
2023-06-26
2026-06-30
Brief Summary
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"HORUS" (Casting light on HOst-cytomegaloviRUs interaction in Solid organ transplantation) study is a European research project, funded by the European Commission (Horizon Europe) involving 16 partners in seven European countries (France, Spain, Czech Republic, Belgium, Switzerland, Germany and Italy) aiming to better characterize the host-CMV interactions in SOT recipients. The first aim of HORUS study will be to build a European cohort of SOT recipients including clinical characterization and the constitution of a biocollection, which is the aim of HORUS cohort, in order to perform biological, immunological, gene expression, viral kinetics and deep viral genome characterization in the global European HORUS project to improve our understanding of the development of a CMV immune response in the context of immunosuppression.
Detailed Description
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"HORUS cohorts" is a project of biological samples biobank from solid organ transplant recipients in Hospitals : France (Bordeaux, Toulouse, Paris, Lyon), Spain (Barcelona), Tchequie (Karlova), Italy (Bologna), Switzerland (Lausanne).
Its main objective of this protocol is to collect, prepare, and store
* under CRB conditions (NFS96900) longitudinal biological samples from solid organ transplants (heart, kidney, lung, liver), from day 0 of transplantation and followed for the occurrence of CMV infection.
* Clinical and sociodemographic data associated with this longitudinal biocollection
The secondary objective is to support for the global "HORUS" project aiming at:
* Studying the longitudinal clinical, viral and immunological profile of solid organ transplants after transplantation with or without CMV disease and if CMV disease with or without a "difficult-to-treat" (CMV persistence, relapse, antiviral drug resistance)
* Defining signatures combining virological data, clinical data, donor/recipient data and immune profile of CMV-specific immunity to identify :i) patients at risk of developing CMV infection and ii) at day 0 of infection to identify patient at risk of developing difficult-to-treat CMV infection. The collection of biological samples, associated with the clinico-biological data, to find the global signature constitutes an indispensable step.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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day 0 of transplantation
This cohort will include 450 patients at the time of transplantation. The following number of participants will be enrolled in the cohort according to strata defined by organ-transplanted type and baseline immune status.
No interventions assigned to this group
day 0 of infection
This cohort will include 150 patients at the time of the infection: Approximatively 75 patients will be drawn from the cohort of solid-organ transplant recipients included at day 0 of transplantation. Additional 75 patients developing a CMV infection will be also included.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years receiving a (living or deceased donor) kidney, lung, liver, and heart allograft,
* written informed consent obtained from subject,
* ability to understand and give their written consent,
* affiliated to health insurance.
* Men and women,
* Age \>= 18 years receiving a (living or deceased donor) kidney, lung, liver, and heart allograft
* written informed consent obtained from subject,
* ability to understand and give their written consent,
* affiliated to health insurance,
* post-transplant CMV infection episode.
Exclusion Criteria
* participant unable or unwilling to comply with study procedures,
* subjects who are legally detained in an official institution.
A cohort 2 of solid-organ transplant recipients at day 0 of infection:
* D-R- recipients,
* participant unable or unwilling to comply with study procedures,
* subjects who are legally detained in an official institution.
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
European Commission
OTHER
Responsible Party
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Principal Investigators
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Laura RICHERT, Pr
Role: STUDY_CHAIR
Clinical Epidemiology Unit at Bordeaux University Hospital
Locations
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Hopitel Pellegrin
Bordeaux, , France
Hôpital Edouard Hériot
Lyon, , France
Hôpital LA PITIE SALPETRIERE
Paris, , France
Hôpital Necker
Paris, , France
Hôpital Foch
Suresnes, , France
Hôpital Rangueil
Toulouse, , France
Hôpital Paul Brousse
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Hannah Kaminski, Dr
Role: primary
Alice Koenig, Dr
Role: primary
Guillaume Coutance, Dr
Role: primary
Camille Roger, Dr
Role: primary
Antoine Roux, Dr
Role: primary
Nassim Kamar, Pr
Role: primary
Faouzi Saliba, Pr
Role: primary
Other Identifiers
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CHUBX 2022/10
Identifier Type: -
Identifier Source: org_study_id