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

NCT05622032 | Completed

• 1 other identifier: Blood virome after haplo-HSCT
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Haploidentical Hematopoietic Stem Cell Transplantation

Keywords

viral infection; blood virome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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 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".

You may not qualify if:

• None

Sponsors & Collaborators

• Laurent Kaiser: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood specimens originating from the above biobank, collected at 4 time points (day 0, 30, 90 and 180) after transplantation.

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Laurent Kaiser, Pr, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Division of Infectious Diseases

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 18, 2022
• Study Start: September 20, 2022
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the publication of the results
• Access Criteria: open access

Locations

CH (1)