Casting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation

NCT05701228 | Active Not Recruiting

• 1 other identifier: CHUBX 2022/10
• Study Type: observational
• Target: 552
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Cytomegalovirus Infections; Solid Organ Transplantation

Keywords

immunocompromised hosts; immune response

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (17)

• Caracterised the solid organ transplants after transplantation

  From inclusion day to month 36

• Caracterised the solid organ transplants after transplantation

  From inclusion day to month 36

• Caracterised the solid organ transplants after transplantation

  From inclusion day to month 36

• Caracterised the solid organ transplants after transplantation

  From inclusion day to month 36

• Caracterised the solid organ transplants after transplantation

  From inclusion day to month 36

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort 1 will include 450 patients at the time of transplantation: Kidney: 6 groups : 50 R+ATG no mTORi, 30 R+ATG mTORi, 50 R+ no ATG no mTORi, 30 R+ no ATG mTORi, 50 D+R- no mTORi, 30 D+R- mTORi Lung: 3 groups of 20 patients R+ ATG,R+ no ATG, D+R- Heart: 3 groups of 30 patients R+ ATG, R+ no ATG, D+R- Liver: 3 groups of 20 patients R+ ATG, R+ no ATG, D+R- Cohort 2 will include 150 patients at the time of the infection: Approximatively 75 patients are expected to roll-over from the cohort of solid-organ transplant recipients included at day 0 of transplantation (cohort 1). Additional 75 patients developing a CMV infection will be also included.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• D-R- recipients,
• participant unable or unwilling to comply with study procedures,
• subjects who are legally detained in an official institution.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• European Commission: collaborator

Study Sites (7)

Hopitel Pellegrin

Bordeaux, 33076, France

Location

Hôpital Edouard Hériot

Lyon, 69003, France

Location

Hôpital LA PITIE SALPETRIERE

Paris, 75013, France

Location

Hôpital Necker

Paris, 75015, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Hôpital Rangueil

Toulouse, 31059, France

Location

Hôpital Paul Brousse

Villejuif, 94804, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected on day 0, day15, M1, M3, M6, M12 and M24 and at the time of clinical events for CMV requiring additional samples at day 0, M1, M2, M4 of infection (M12 of infection for patients only included at day 0 of infection).

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Laura RICHERT, Pr

  Clinical Epidemiology Unit at Bordeaux University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 27, 2023
• Study Start: June 26, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

FR (7)