NCT07181330

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

Retrospective Clinical Validation of the SE-SPTM-PCR Platform for Hcmv-miR-UL22A-5p Detection in Monitoring Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Ting YANG · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the clinical performance of a novel microRNA-based detection platform, SE-SPTM-PCR, for identifying cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (HSCT). Specifically, the study retrospectively analyzes plasma samples to determine whether hcmv-miR-UL22A-5p can serve as a sensitive and specific biomarker for CMV reactivation. Results will be compared to traditional CMV DNA testing methods.

Detailed description

Cytomegalovirus (CMV) reactivation is a frequent and serious complication after allogeneic hematopoietic stem cell transplantation (HSCT), potentially leading to CMV disease, graft-versus-host disease, and increased transplant-related mortality. Early and accurate monitoring of CMV infection is critical for timely treatment. Traditional CMV monitoring relies on the detection of CMV DNA in blood using quantitative PCR. However, this method may have limited sensitivity in early infection stages or low viral load situations. MicroRNAs encoded by CMV, such as hcmv-miR-UL22A-5p, are small non-coding RNAs released into circulation during viral activity and may serve as alternative biomarkers. This study retrospectively evaluates a novel microRNA-based detection platform, SE-SPTM-PCR (Selective Enrichment and Specific Probe Terminal Mediated PCR), for its ability to detect hcmv-miR-UL22A-5p in plasma samples from HSCT recipients. The goal is to determine whether this method improves the sensitivity and specificity of CMV reactivation monitoring compared to standard CMV DNA testing. Archived plasma samples from post-HSCT patients with known CMV DNA status (positive or negative) will be tested. The diagnostic performance of SE-SPTM-PCR will be assessed through ROC curve analysis, correlation with DNA viral load, and comparison of sensitivity and specificity. Findings from this study may support the use of hcmv-miR-UL22A-5p as a more sensitive and stable biomarker for CMV reactivation, and promote the clinical application of SE-SPTM-PCR in transplant monitoring strategies.

Conditions

• Cytomegalovirus Infections
• Hematopoietic Stem Cell Transplantation (HSCT)
• CMV Reactivation
• ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-06
• Primary completion: 2021-05-06
• Completion: 2025-06-18
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: China