Clinical Performance of SE-SPTM-PCR in Detecting Hcmv-miR-UL22A-5p After Hematopoietic Stem Cell Transplantation

CompletedOBSERVATIONAL
Enrollment

60

Participants

Timeline

Start Date

May 6, 2021

Primary Completion Date

May 6, 2021

Study Completion Date

June 18, 2025

Conditions
Cytomegalovirus InfectionsHematopoietic Stem Cell Transplantation (HSCT)CMV ReactivationALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
Interventions
DIAGNOSTIC_TEST

SE-SPTM-PCR microRNA assay

SE-SPTM-PCR (Selective Enrichment and Specific Probe Terminal Mediated PCR) is a microRNA-based diagnostic assay designed to detect hcmv-miR-UL22A-5p in human plasma. In this retrospective observational study, the assay is used on archived plasma samples collected from patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT). The purpose is to evaluate the diagnostic performance of this method in identifying CMV reactivation, compared to standard CMV DNA qPCR testing. This test was not assigned or administered as part of patient care but is the primary focus of retrospective laboratory analysis.

Trial Locations (1)

350001

The First Affiliated Hospital of Fujian Medical University, Fuzhou

All Listed Sponsors
lead

Ting YANG

OTHER