Clinical Trial

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

Study acronym: HSCT-HCMV01
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07210242
Lead Sponsor Ting YANG
Collaborators: First Affiliated Hospital of Fujian Medical University, Xiamen University
Conditions Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation, Virus Reactivation, Graft vs Host Disease
Enrollment 300 participants
Start Date 2025-10-10
Primary Completion 2028-10-10 (estimated)
Study Completion 2028-10-10 (estimated)
Updated on ClinicalTrials.gov 2025-10-07