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

Sponsor
Laurent Kaiser (Other)
Overall Status
Recruiting
CT.gov ID
NCT05622032
Collaborator
(none)
58
Enrollment
1
Location
4.4
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    58 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Blood Virome After Haploidentical Hematopoietic Stem Cell Transplantation, a Pilot Study
    Actual Study Start Date :
    Sep 20, 2022
    Anticipated Primary Completion Date :
    Jan 31, 2023
    Anticipated Study Completion Date :
    Jan 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Describe the blood virome in haploidentical and HLA-matched allo-HSCT recipients during the first 6 months after transplantation. [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Geneva University Hospitals Geneva Switzerland 1205

    Sponsors and Collaborators

    • Laurent Kaiser

    Investigators

    • Principal Investigator: Laurent Kaiser, Pr, MD, Hôpitaux Universitaires de Genève

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laurent Kaiser, Head, Division of Infectious Diseases, University Hospital, Geneva
    ClinicalTrials.gov Identifier:
    NCT05622032
    Other Study ID Numbers:
    • Blood virome after haplo-HSCT
    First Posted:
    Nov 18, 2022
    Last Update Posted:
    Nov 28, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Laurent Kaiser, Head, Division of Infectious Diseases, University Hospital, Geneva
    viral infection
    blood virome

    Study Results

    No Results Posted as of Nov 28, 2022