Cytomegalovirus InfectionsSolid Organ Transplantation
Study summary
CMV disease remains the most frequent infectious complication post-transplant and it is associated to high morbidity and even mortality. Global efforts from both transplant physicians and researchers in the field is needed to better characterize the host-virus interactions in the transplant setting, with the aim of decreasing the burden of disease and improve the well-being of patients.
"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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
A cohort 1 of solid-organ transplant recipients at day 0 of transplantation will be included:
* Consecutive patients meeting the following inclusion criteria will be included:
* 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.
* Exclusion criteria would be:
* D-R- recipients,
* 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:
* Consecutive patients meeting the following inclusion criteria will be included:
* 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 would be:
* D-R- recipients,
* participant unable or unwilling to comply with study procedures,
* subjects who are legally detained in an official institution.
Primary outcome measure(s)
Biobank inventory for cohort 1 : day 0 of transplantation — from day of graft (inclusion day) to month 24 Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.
Biobank inventory for cohort 1 : day 0 of transplantation — from day of graft (inclusion day) to month 24 Biobank inventory will be caracterise thanks to : total volume
Biobank inventory for cohort 1 : day 0 of transplantation — from day of graft (inclusion day) to month 24 Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies.
Biobank inventory for cohort 1 : day 0 of transplantation — from day of graft (inclusion day) to month 24 Biobank inventory will be caracterise thanks to : date of extraction
Biobank inventory for cohort 1 : day 0 of transplantation — from day of graft (inclusion day) to month 24 Biobank inventory will be caracterise thanks to : concentration of DNA and RNA
Biobank inventory for cohort 2 : day 0 of infection — from day of infection (inclusion day) to month 12 Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.
Biobank inventory for cohort 2 : day 0 of infection — from day of infection (inclusion day) to month 12 Biobank inventory will be caracterise thanks to : total volume
Biobank inventory for cohort 2 : day 0 of infection — from day of infection (inclusion day) to month 12 Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies,
Biobank inventory for cohort 2 : day 0 of infection — from day of infection (inclusion day) to month 12 Biobank inventory will be caracterise thanks to : date of extraction,
Biobank inventory for cohort 2 : day 0 of infection — from day of infection (inclusion day) to month 12 Biobank inventory will be caracterise thanks to : total volume and concentration of DNA and RNA
Biobank inventory for cohort 2 : day 0 of infection — from day of infection (inclusion day) to month 12 Biobank inventory will be caracterise thanks to : concentration of DNA and RNA
Creation of a Clinical Database — From inclusion day to month 36 Implementation of a centralized data base with clinical and sociodemographic data from all European clinical sites.
Trial sites (7)
Facility
City
Region
Status
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
More University Hospital, Bordeaux trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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