Casting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation

Cytomegalovirus Infections Clinical Trial

— HORUS  

Official title:

Casting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701228
• Other study ID #: CHUBX 2022/10
• Status: Recruiting
• Start date: June 26, 2023
• Est. completion date: June 2026

Study information

• Verified date: June 2023
• Source: University Hospital, Bordeaux
• Contact: Hannah KAMINSKI, Dr
• Phone: 5 56 79 55 38
• Email: hannah.kaminski[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The overall goal of HORUS study is to improve our understanding of the host-virus relationship of Cytomegalovirus within immunocompromised solid organ transplant recipients in order to propose both knowledge improvement, and clinical immune signatures for decreasing CMV infections/diseases incidence and avoiding the use of toxic antiviral therapy. HORUS' general goal is to enhance our knowledge on risk factors, disease progression and clinical outcomes by analyzing together immune host characteristics, viral characteristics and immunosuppressive drugs. The constitution of two clinical cohorts ("The day 0 of graft cohort" and "the day 0 of infection cohort") will constitute the aim of "HORUS study" with clinical data collection and biocollection which will be used in the global HORUS project to identify immune profiles of patients integrating all the actors involved in viral control, viral and clinical parameters associated with a higher risk of CMV replication and an evolution toward a CMV difficult-to-treat disease. "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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Solid Organ Transplantation

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	European Commission

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biobank inventory for cohort 1 : day 0 of transplantation	Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.	from day of graft (inclusion day) to month 24
Primary	Biobank inventory for cohort 1 : day 0 of transplantation	Biobank inventory will be caracterise thanks to : total volume	from day of graft (inclusion day) to month 24
Primary	Biobank inventory for cohort 1 : day 0 of transplantation	Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies.	from day of graft (inclusion day) to month 24
Primary	Biobank inventory for cohort 1 : day 0 of transplantation	Biobank inventory will be caracterise thanks to : date of extraction	from day of graft (inclusion day) to month 24
Primary	Biobank inventory for cohort 1 : day 0 of transplantation	Biobank inventory will be caracterise thanks to : concentration of DNA and RNA	from day of graft (inclusion day) to month 24
Primary	Biobank inventory for cohort 2 : day 0 of infection	Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.	from day of infection (inclusion day) to month 12
Primary	Biobank inventory for cohort 2 : day 0 of infection	Biobank inventory will be caracterise thanks to : total volume	from day of infection (inclusion day) to month 12
Primary	Biobank inventory for cohort 2 : day 0 of infection	Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies,	from day of infection (inclusion day) to month 12
Primary	Biobank inventory for cohort 2 : day 0 of infection	Biobank inventory will be caracterise thanks to : date of extraction,	from day of infection (inclusion day) to month 12
Primary	Biobank inventory for cohort 2 : day 0 of infection	Biobank inventory will be caracterise thanks to : total volume and concentration of DNA and RNA	from day of infection (inclusion day) to month 12
Primary	Biobank inventory for cohort 2 : day 0 of infection	Biobank inventory will be caracterise thanks to : concentration of DNA and RNA	from day of infection (inclusion day) to month 12
Primary	Creation of a Clinical Database	Implementation of a centralized data base with clinical and sociodemographic data from all European clinical sites.	From inclusion day to month 36
Secondary	Caracterised the solid organ transplants after transplantation	Assessing the longitudinal clinical profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (CMV persistence)	From inclusion day to month 36
Secondary	Caracterised the solid organ transplants after transplantation	Assessing the longitudinal clinical profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (relapse)	From inclusion day to month 36
Secondary	Caracterised the solid organ transplants after transplantation	Assessing the longitudinal clinical profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (antiviral drug resistance)	From inclusion day to month 36
Secondary	Caracterised the solid organ transplants after transplantation	Assessing the longitudinal viral profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (CMV persistence)	From inclusion day to month 36
Secondary	Caracterised the solid organ transplants after transplantation	Assessing the longitudinal viral profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (relapse)	From inclusion day to month 36
Secondary	Caracterised the solid organ transplants after transplantation	Assessing the longitudinal viral profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (antiviral drug resistance)	From inclusion day to month 36
Secondary	Caracterised the solid organ transplants after transplantation	Assessing the longitudinal immunological profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (CMV persistence)	From inclusion day to month 36
Secondary	Caracterised the solid organ transplants after transplantation	Assessing the longitudinal immunological profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (relapse)	From inclusion day to month 36
Secondary	Caracterised the solid organ transplants after transplantation	Assessing the longitudinal immunological profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (antiviral drug resistance)	From inclusion day to month 36
Secondary	CMV caracterisation	Defining signatures combining virological data profile of CMV-specific immunity to identify patients at risk of developing CMV infection.	From inclusion day to month 36
Secondary	CMV caracterisation	Defining signatures combining clinical data profile of CMV-specific immunity to identify patients at risk of developing CMV infection.	From inclusion day to month 36
Secondary	CMV caracterisation	Defining signatures combining donor/recipient data profile of CMV-specific immunity to identify patients at risk of developing CMV infection.	From inclusion day to month 36
Secondary	CMV caracterisation	Defining signatures combining immune profile of CMV-specific immunity to identify patients at risk of developing CMV infection.	From inclusion day to month 36
Secondary	CMV infection caracterisation	Defining signatures combining virological data profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.	From day of infection (inclusion day) to month 36
Secondary	CMV infection caracterisation	Defining signatures combining clinical data profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.	From day of infection (inclusion day) to month 36
Secondary	CMV infection caracterisation	Defining signatures combining donor/recipient data profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.	From day of infection (inclusion day) to month 36
Secondary	CMV infection caracterisation	Defining signatures combining immune profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.	From day of infection (inclusion day) to month 36