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Cytomegalovirus (CMV) Reactivation in Allogeneic HSCT Recipient

NCT03806764 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2023-06-01

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Infections
  • Haematological Malignancy
  • Organ or Tissue Transplant; Complications
  • Immune Suppression

Interventions

DIAGNOSTIC_TEST

Blood sampling

Blood sampling from prospective study participants will be taken for immune functions measurements

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    collaborator OTHER

  • Western Sydney Local Health District

    collaborator OTHER

  • Walter and Eliza Hall Institute of Medical Research

    collaborator OTHER

  • Austin Hospital, Melbourne Australia

    collaborator OTHER

  • Melbourne Health

    lead OTHER

Principal Investigators

  • Monica Slavin, MBBS FRACP · Melbourne Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806764 on ClinicalTrials.gov