Blood Virome After Haploidentical Hematopoietic Stem Cell Transplantation, a Pilot Study

The goal of this observational study is to assess the risk of viral infections in patients receiving hematopoietic stem cell transplantation (HSCT) from a haploidentical donor compared to those who receive HSCT from a HLA-matched donor. The main question it aims to answer is: to describe which viruses are replicating in the blood of the above two patient groups on the day of transplantation and at 1, 3 and 6 months after transplantation. Blood samples taken as part of routine care on the day of transplantation and at 1, 3 and 6 months post-transplantation visits are analyzed and the types and amount of viruses detected in the two groups of patients are described.

Study Overview

• Status: Completed
• Conditions: Haploidentical Hematopoietic Stem Cell Transplantation

Detailed Description

Geneva University Hospitals are one of the three centers performing allogeneic HSCT in Switzerland. Since several years the Division of infectious diseases runs a collaborative research program with the Division of Hematology. In 2015 the two divisions jointly created a prospective cohort of allo-HSCT patients called: "Infectious diseases in hematopoietic stem cell transplant patients cohort" enrolling potentially all adult patients engrafted in our center since 2015 (CCER protocol 15-120 and relative amendments). The cohort compiles clinical data on hematological and infectious complications occurring up to one year after transplantation and biological specimen collected systematically until up to 2 years after transplantation, which are stored in a joint biobank.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients receiving allogeneic HSCT at the Geneva University Hospitals from a haploidentical or from an HLA-matched donor, who signed the informed consent form before transplantation for inclusion in the prospective cohort of "Infectious disease in hematopoietic stem cell transplant patients".

Description

Inclusion Criteria:

• Adult patients receiving allogeneic stem cell transplantation at the Geneva University Hospitals from a haploidentical or from an HLA-matched donor, who signed the informed consent form before transplantation for inclusion in the prospective cohort of "Infectious disease in hematopoietic stem cell transplant patients".

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
haploidentical HSCT patients; Patients receiving HSCT from a haploidentical donor. They also receive a treatment called cyclophosphamide as part of the protocol to prevent graft versus host disease at day 3 and 4 after transplantation.
HLA-matched HSCT patients; Patients who receive HSCT from a HLA-matched donor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the blood virome in haploidentical and HLA-matched allo-HSCT recipients during the first 6 months after transplantation.	Describe the types of viruses detected as well as their frequency in the blood virome of haplo- HSCT patients compared to the HLA-matched group by metagenomic next generation sequencing	6 months after transplantation

Collaborators and Investigators

• Sponsor: Laurent Kaiser
• Investigators: Principal Investigator: Laurent Kaiser, Pr, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): March 25, 2025
• Study Completion (Actual): March 25, 2025

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: viral infection; blood virome
• Other Study ID Numbers: Blood virome after haplo-HSCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Datasets originating from our project and used in case of the publication of our results will be deposited on the institutional open access data repository: Yareta and will be made public at the time of the publication. Metadata will be searchable and discoverable. Concerning the mNGS data, in case of scientific publication, raw data will be deposited in the publicly available repository Sequence Read Archive (SRA) from NCBI.
• IPD Sharing Time Frame: After the publication of the results
• IPD Sharing Access Criteria: open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No