Hematopietic Stem Cell TransplantationGeBVirNCT03642977
DNA and RNA Viruses of the Blood Virome of Allogeneic Hematopoietic Stem Cell Transplant Recipients
An observational study of Hematopietic Stem Cell Transplantation and Blood Virome, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopietic Stem Cell Transplantation, Blood Virome, RNA Virus Infections
- What is being tested?
- Real time PCR and RT-PCR for DNA and RNA viral species
- How many people
- 112 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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"
Who may be able to join
- 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
Who cannot join
- Absence of a signed informed consent form for the "Cohort of infectious disease in hematopoietic stem cell transplant patients".
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Hematopietic Stem Cell Transplantation, Blood Virome, RNA Virus Infections, DNA Virus Infections
- Being tested
- Real time PCR and RT-PCR for DNA and RNA viral species
- Keywords
- Longitudinal study, Real time PCR
- Medical subject headings
- RNA Virus Infections, DNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real time PCR and RT-PCR for DNA and RNA viral speciesDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Diagnostic Test: Real time PCR and RT-PCR for DNA and RNA viral species |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one-year period after transplantation
Secondary outcomes (2)
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
Measured: 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
Measured: one-year period after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Mar 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Marie-Céline Zanella, University Hospital, Geneva
- Investigators
- Marie-Céline Zanella, Principal investigator, University Hospitals of GenevaLaurent Kaiser, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642977
- Sponsor's protocol ID
- Protocol 2017-01304
- Acronym
- GeBVir
- Status last verified
- Jan 2021
- First submitted
- 30 Jul 2018
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03642977
- Acronym / sponsor ID
- GeBVir / Protocol 2017-01304
- Conditions
- Hematopietic Stem Cell Transplantation, Blood Virome, RNA Virus Infections, DNA Virus Infections
- Keywords
- Longitudinal study, Real time PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- 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
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic HSCT recipients | – | Diagnostic Test: Real time PCR and RT-PCR for DNA and RNA viral speciesAdult 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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"
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Absence of a signed informed consent form for the "Cohort of infectious disease in hematopoietic stem cell transplant patients".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real time PCR and RT-PCR for DNA and RNA viral speciesQualitative 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). | Diagnostic test | Allogeneic HSCT recipients |
Primary outcome
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).
2 secondary outcomes
Prevalence of plasmatic detection of DNA and RNA viruses
Time frame: one-year period after transplantation
Cumulative incidence of DNA and RNA viruses plasmatic detection
Time frame: one-year period after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Céline Zanella principal investigator
University Hospitals of Geneva
Laurent Kaiser principal investigator
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopietic Stem Cell Transplantation and Blood Virome, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmatic viral load kinetics of DNA and RNA viruses (time frame: one-year period after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.