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

NCT ID: NCT05622032

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-20

Study Completion Date

2025-03-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Haploidentical Hematopoietic Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

HLA-matched HSCT patients

Patients who receive HSCT from a HLA-matched donor.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laurent Kaiser

OTHER

Sponsor Role lead

Responsible Party

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Laurent Kaiser

Head, Division of Infectious Diseases

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Laurent Kaiser, Pr, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Blood virome after haplo-HSCT

Identifier Type: -

Identifier Source: org_study_id

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