Blood Virome After Haploidentical Hematopoietic Stem Cell... | NCT05622032

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

NCT05622032

Sponsor

Laurent Kaiser

Status

Completed

Last Update Posted

Apr 2, 2025Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Haploidentical Hematopoietic Stem Cell Transplantation

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2022Actual

Primary Completion Date

Mar 25, 2025Actual

Completion Date

Mar 25, 2025Actual

First Submitted Date

Nov 10, 2022

First Submission Date that Met QC Criteria

Nov 10, 2022

First Posted Date

Nov 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2025

Last Update Posted Date

Apr 2, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laurent Kaiser, Head, Division of Infectious Diseases, University Hospital, GenevaSponsor-Investigator

Lead Sponsor

Laurent KaiserOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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".

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurent Kaiser, Pr, MD	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geneva University Hospitals		Geneva		1205	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

After the publication of the results

Access Criteria

open access

URL

Not provided