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NCT Number: NCT03642977

DNA and RNA Viruses of the Blood Virome of Allogeneic Hematopoietic Stem Cell Transplant Recipients

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.

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Key information

Conditions

Hematopietic Stem Cell Transplantation Blood Virome DNA Virus Infections Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Geneva

Geneva, 1205, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

Real time PCR and RT-PCR for DNA and RNA viral species

Diagnostic Test

Qualitative and quantitative real time PCR and RT-PCR assays will be performed on hematopoietic stem cell transplant recipients' plasma samples collected at five specific time points over a one-year period after transplantation (the day of transplantation (D0), 30 days (D30), 3 months (M3), 6 months (M6) and one year (Y1) after transplantation), for the screening of a selection of at least 21 DNA and RNA viruses (belonging to the Herpesviridae, Polyomaviridae, Adenoviridae, Parvoviridae, Anelloviridae, Picornaviridae and Flaviviridae families).

Primary outcomes

  1. Plasmatic viral load kinetics of DNA and RNA viruses

    Time frame: one-year period after transplantation

    Measurement of the plasmatic viral load of DNA and RNA viruses belonging to the Herpesviridae, Polyomaviridae, Adenoviridae, Parvoviridae, Anelloviridae, Picornaviridae and Flaviviridae families, with real time (RT-)PCR on plasma samples collected at pre-specified timepoints (the day of transplantation (D0), 30 days (D30), 3 months (M3), 6 months (M6) and one year (Y1) after transplantation) (expressed as fold-increase).

Secondary outcomes

  1. Prevalence of plasmatic detection of DNA and RNA viruses

    Time frame: one-year period after transplantation

    Detection of DNA and RNA viruses using real time (RT-)PCR performed on plasma samples collected at pre-specified timepoints

  2. Cumulative incidence of DNA and RNA viruses plasmatic detection

    Time frame: one-year period after transplantation

    Detection of DNA and RNA viruses using real time (RT-)PCR performed on plasma samples collected at pre-specified timepoints

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Dr Diem-Lan Vu Cantero
  • Dr Dionysios Neofytos
  • Dr Federico Simonetta
  • Dr Samuel Cordey
  • Dr Stavroula Masouridi-Levrat
  • Prof Christian Van Delden
  • Prof Laurent Kaiser
  • Prof Yves Chalandon

Registry information

Official study 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)

Acronym: GeBVir

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2018
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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