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

Completed

• Conditions: DNA Virus Infections; Hematopietic Stem Cell Transplantation; Blood Virome; RNA Virus Infections
• Interventions: Diagnostic Test: Real time PCR and RT-PCR for DNA and RNA viral species

• Registration Number: NCT03642977
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allogeneic HSCT recipients	Real time PCR and RT-PCR for DNA and RNA viral species	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".

Primary Outcome Measures

Name	Time	Method
Plasmatic viral load kinetics of DNA and RNA viruses	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 Outcome Measures

Name	Time	Method
Prevalence of plasmatic detection of DNA and RNA viruses	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
Cumulative incidence of DNA and RNA viruses plasmatic detection	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

Trial Locations

Locations (1)

University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland