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

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)

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.

Study Overview

• Status: Completed
• Conditions: RNA Virus Infections; DNA Virus Infections; Hematopietic Stem Cell Transplantation; Blood Virome
• Intervention / Treatment: Diagnostic test: Real time PCR and RT-PCR for DNA and RNA viral species

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.

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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"

Description

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".

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Allogeneic HSCT recipients; Adult patients receiving allogeneic hematopoietic stem cell transplant (HSCT) at University Hospitals of Geneva and who are enrolled in the "Cohort of infectious disease in hematopoietic stem cell transplant patients".

Diagnostic test: Real time PCR and RT-PCR for DNA and RNA viral species; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasmatic viral load kinetics of DNA and RNA viruses	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).	one-year period after transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of plasmatic detection of DNA and RNA viruses	Detection of DNA and RNA viruses using real time (RT-)PCR performed on plasma samples collected at pre-specified timepoints	one-year period after transplantation
Cumulative incidence of DNA and RNA viruses plasmatic detection	Detection of DNA and RNA viruses using real time (RT-)PCR performed on plasma samples collected at pre-specified timepoints	one-year period after transplantation

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Prof Laurent Kaiser; Dr Samuel Cordey; Dr Stavroula Masouridi-Levrat; Prof Christian Van Delden; Prof Yves Chalandon; Dr Dionysios Neofytos; Dr Federico Simonetta; Dr Diem-Lan Vu Cantero
• Investigators: Principal Investigator: Marie-Céline Zanella, University Hospitals of Geneva; Principal Investigator: Laurent Kaiser, University Hospitals of Geneva

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (ACTUAL): August 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Longitudinal study; Real time PCR
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Virus Diseases; RNA Virus Infections; DNA Virus Infections
• Other Study ID Numbers: Protocol 2017-01304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No