Clinical trial NCT03642977: DNA and RNA Viruses of the Blood Virome of Allogeneic Hematopoietic Stem Cell Transplant Recipients
Official title: DNA and RNA Viruses of the Blood Virome of Allogeneic Hematopoietic Stem Cell Transplant Recipients: a Longitudinal Observational Study During a One-year Period After Transplantation - the Geneva Blood Virome Project (GeBVir)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopietic Stem Cell Transplantation
Blood Virome
RNA Virus Infections
DNA Virus Infections
Keywords: Longitudinal study
Real time PCR
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Prof Laurent Kaiser
name: Dr Samuel Cordey
name: Dr Stavroula Masouridi-Levrat
name: Prof Christian Van Delden
name: Prof Yves Chalandon
name: Dr Dionysios Neofytos
name: Dr Federico Simonetta
name: Dr Diem-Lan Vu Cantero
First posted: 2018-08-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients receiving allogeneic stem cell transplantation at University Hospitals of Geneva and who are enrolled in an already existing monocentric cohort named "Cohort of infectious disease in hematopoietic stem cell transplant patients"

Brief summary: The Geneva Blood Virome Project is a longitudinal observational study. The main objective is to describe the kinetics of the plasmatic viral load of a selection of at least 21 DNA and RNA viruses of the blood virome in allogeneic hematopoietic stem cell transplant recipients, over a one-year period after transplantation. Secondary objectives are: 1) to assess the prevalence of DNA and RNA viruses plasmatic detections and co-detections, 2) to assess the cumulative incidence of DNA and RNA viruses plasmatic detection. The population of the study consists in adult patients receiving allogeneic stem cell transplantation at the University Hospitals of Geneva, enrolled in an already existing monocentric cohort, and for which clinical specimens are collected and stored at the time and after transplantation. The investigators plan to include 120 patients whose plasma samples are collected from March 2017 and to systematically use plasma samples collected on the day of transplantation and several time points after transplantation to screen DNA and RNA viruses by qualitative and quantitative real-time PCR and RT-PCR.

Detailed description: The Geneva Blood Virome Project is a longitudinal observational study. The main objective is to describe the kinetics of the plasmatic viral load of a selection of at least 21 DNA and RNA viruses of the blood virome (Herpesviridae Polyomaviridae, Adenoviridae, Parvoviridae, Anelloviridae, Picornaviridae and Flaviviridae) in allogeneic hematopoietic stem cell transplant recipients, over a period of one year after transplantation. These DNA and RNA viruses can be responsible of acute infections, chronic infections or reactivations after transplantation. Secondary objectives are : 1) to assess the prevalence of DNA and RNA viruses plasmatic detections and co-detections at pre-specified time-points, 2) to assess the cumulative incidence of DNA and RNA viruses plasmatic detection at pre-specified time-points. The population of the study consists in adult patients receiving allogeneic stem cell transplantation at the University Hospitals of Geneva and who are enrolled in an already existing monocentric cohort named "Cohort of infectious disease in hematopoietic stem cell transplant patients" and for which clinical specimens are collected and stored at the time and after transplantation. The investigators plan to include 120 patients whose plasma samples are collected from March 2017 and to systematically use plasma samples collected at 5 pre-specified time points (the day of transplantation, 30 days, 3 months, 6 months, and one year after transplantation) to perform qualitative and quantitative real-time r(RT)-PCR assays for the screening of DNA and RNA viruses. The definitive analysis of results should be done by the end of 2020.

Eligibility criteria: Inclusion Criteria:

* Adult patients receiving allogeneic stem cell transplantation since March 2017 at University Hospitals of Geneva
* Enrollment in the "Cohort of infectious disease in hematopoietic stem cell transplant patients"
* Signature of an informed consent form before transplantation

Exclusion Criteria:

* Absence of a signed informed consent form for the "Cohort of infectious disease in hematopoietic stem cell transplant patients".

Primary outcomes:
measure: Plasmatic viral load kinetics of DNA and RNA viruses
timeFrame: one-year period after transplantation
Secondary outcomes:
measure: Prevalence of plasmatic detection of DNA and RNA viruses
timeFrame: one-year period after transplantation
measure: Cumulative incidence of DNA and RNA viruses plasmatic detection
timeFrame: one-year period after transplantation
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University Hospitals of Geneva
name: Marie-Céline Zanella
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals of Geneva
name: Laurent Kaiser
role: PRINCIPAL_INVESTIGATOR
References: