Cytomegalovirus (CMV) Reactivation in Allogeneic HSCT Recipient
CReSCT
Assessing the Impact and Complications of Cytomegalovirus (CMV) Reactivation in a Multi-site Study of Allogeneic Haematopoietic Stem Cell Transplant Recipient
1 other identifier
interventional
370
1 country
1
Brief Summary
This study consists of two parts: 1) Part 1, a retrospective part on 250 consecutive patients following allogeneic haematopoietic stem cell transplant (allo-HSCT) at the Royal Melbourne Hospital from 2012 to 2017, inclusive, and 2) Part 2, a prospective part on 120 allo-HSCT patients from 4 sites in Australia: the Royal Melbourne Hospital, Peter MacCallum Cancer Centre, Austin Hospital, and Westmead Hospital. In Part 1, medical records of allo-HSCT recipients will be evaluated to determine the incidence and clinical outcomes of CMV viremia post HSCT, including both the direct (CMV disease) and indirect (such as invasive fungal infection, other viral infections, bacterial infection) effects on clinical outcomes. In Part 2, allo-HSCT participants at risk of CMV disease will be assessed to determine the association of host CMV-specific immunity with clinical management and outcomes over one year post allo-HSCT. The overall aims of the study are to establish if CMV infection in allo-HSCT patients are associated with poor clinical outcomes; and whether measurement of immunological functions could provide an early indicator to identify patients at risk and appropriate timing for initiation of CMV treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2018
CompletedFirst Submitted
Initial submission to the registry
January 7, 2019
CompletedFirst Posted
Study publicly available on registry
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 1, 2023
May 1, 2023
5.7 years
January 7, 2019
May 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence and outcome of CMV viremia
The incidence and outcome of clinically relevant CMV viremia post HSCT will be assessed
250 retrospective cases of HSCTduring 2012 to 2017, inclusive, will be reviewed from the day of transplant to 6 months post transplant.
Host CMV-specific T cell immunity and related clinical outcomes
Host CMV-specific T cell immunity status of 120 participants will be assessed prospectively against CMV related clinical outcomes to establish if correlations exist
52 weeks following HSCT
Secondary Outcomes (4)
Low level CMV viremia
250 retrospective cases of HSCTduring 2012 to 2017, inclusive, will be reviewed from the day of transplant to 6 months post transplant.
Economic cost for managing CMV infection
250 retrospective cases of HSCTduring 2012 to 2017, inclusive, will be reviewed from the day of transplant to 6 months post transplant.
CMV viral load for initiation of treatment
52 weeks following HSCT
Correlation of host T cell function and risk of CMV infection
52 weeks following HSCT
Study Arms (2)
Retrospective study
NO INTERVENTIONMedical records of 250 allo-HSCT recipients will be evaluated retrospectively to determine the incidence and clinical outcomes of CMV viremia post HSCT, including both the direct (CMV disease) and indirect (such as invasive fungal infection, other viral infections, bacterial infection) effects on clinical outcomes.
Prospective study
OTHER120 recipients of allo-HSCT will be recruited into the prospective part of the study. Participants will be reviewed pre-transplant, 6, 12, 24 and 52 weeks following HSCT during routine clinical visits. clinical assessment will be made such as CMV viremia, transplant related complications and current medications. Participants who are at high risk of CMV will have study blood sampling taken to assess immune functions
Interventions
Blood sampling from prospective study participants will be taken for immune functions measurements
Eligibility Criteria
You may qualify if:
- For the retrospective cohort, all 250 consecutive allo-HSCT patients between 2012 to 2017 at the Royal Melbourne Hospital will be included, with CMV-negative patients acting as controls for economic comparisons.
- For the prospective cohort, patients undergoing allo-HSCT, at risk of CMV disease (D+/R+, D-/R+ D+/R-), and able to provide informed consent.
You may not qualify if:
- For the prospective cohort, patients who has CMV disease at the time of enrolment and patients who are unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Melbourne Healthlead
- Peter MacCallum Cancer Centre, Australiacollaborator
- Western Sydney Local Health Districtcollaborator
- Walter and Eliza Hall Institute of Medical Researchcollaborator
- Austin Hospital, Melbourne Australiacollaborator
Study Sites (1)
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monica Slavin, MBBS FRACP
Melbourne Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Infectious Diseases Physician
Study Record Dates
First Submitted
January 7, 2019
First Posted
January 16, 2019
Study Start
April 17, 2018
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
June 1, 2023
Record last verified: 2023-05