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

NCT03642977 | Completed

• 1 other identifier: Protocol 2017-01304
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Longitudinal study; Real time PCR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prevalence of plasmatic detection of DNA and RNA viruses

  one-year period after transplantation

• Cumulative incidence of DNA and RNA viruses plasmatic detection

  one-year period after transplantation

Study Arms (1)

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

Interventions

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).

Allogeneic HSCT recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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"

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Prof Laurent Kaiser: collaborator
• Dr Samuel Cordey: collaborator
• Dr Stavroula Masouridi-Levrat: collaborator
• Prof Christian Van Delden: collaborator
• Prof Yves Chalandon: collaborator
• Dr Dionysios Neofytos: collaborator
• Dr Federico Simonetta: collaborator
• Dr Diem-Lan Vu Cantero: collaborator

Study Sites (1)

University Hospitals of Geneva

Geneva, 1205, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma specimens

MeSH Terms

Conditions

RNA Virus Infections; DNA Virus Infections

Interventions

DNA, B-Form

Condition Hierarchy (Ancestors)

Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

DNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Nucleic Acid Conformation; Molecular Conformation; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Marie-Céline Zanella

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

• Laurent Kaiser

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 22, 2018
• Study Start: March 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

CH (1)