HCMV-miRNA Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation Using PSTM-qPCR

ConditionsCytomegalovirus Infections Hematopoietic Stem Cell Transplantation Virus Reactivation Graft vs Host Disease

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorTing YANG

About this trial

Human cytomegalovirus (HCMV) infection is one of the most common and serious complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Standard monitoring uses HCMV DNA testing, but this method may not detect the virus early enough to guide timely treatment.

This multicenter observational study will evaluate a new high-performance microRNA (miRNA) detection technology (PSTM-qPCR) for monitoring HCMV infection in allo-HSCT patients. Approximately 300 patients and their donors will be enrolled across several major transplant centers in China. Blood samples will be collected before and after transplantation to test for both HCMV-miRNA and HCMV-DNA. The study will compare the sensitivity and timing of miRNA detection with conventional DNA testing and explore whether miRNA can serve as an early biomarker of infection and related complications.

The goal is to improve early diagnosis and management of HCMV infection, reduce infection-related complications, and ultimately improve survival outcomes in patients undergoing allo-HSCT.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Pregnant or breastfeeding women.

Trial population

This study will include patients scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) at participating transplant centers in China, along with their corresponding stem cell donors. Eligible recipients are patients with hematologic malignancies or related disorders who meet transplant indications. Stem cell sources include peripheral blood stem cells and/or bone marrow plus peripheral blood. All participants must voluntarily join the study and provide written informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants

are grouped into 1 trial group

Group A: Allo-HSCT Recipients and Donors

Trial outcomes

Primary outcomes

Diagnostic performance of HCMV-miRNA compared with HCMV-DNA

Evaluate the diagnostic accuracy of HCMV-miRNA detection (using PSTM-qPCR) compared with conventional HCMV-DNA testing for early identification of cytomegalovirus infection or reactivation in allo-HSCT recipients. Outcome measures include sensitivity, specificity, and time to first positive result.

Time frame

From pre-conditioning (baseline, before allo-HSCT) through 12 months post-transplantation

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ting YANG

Lead sponsor

Fujian Medical University

Sponsor institution

First Affiliated Hospital of Fujian Medical University

Collaborator

Xiamen University