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

Ting YANG

Status: Completed

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

Treatments: Diagnostic Test: SE-SPTM-PCR microRNA assay

Study type: Observational

Funder types: Other

Identifiers

NCT07181330

FMU-XMU-SESPTM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Patients who received allogeneic hematopoietic stem cell transplantation (HSCT)

Availability of archived plasma samples collected within 100 days post-transplant

Documented CMV DNA testing results corresponding to the plasma sample

Age ≥ 18 years

Exclusion criteria

Lack of corresponding CMV DNA testing results

Inadequate volume or quality of archived plasma sample for analysis

Concurrent active infections with other viruses (e.g., EBV, HBV, HCV) at time of plasma collection

Patients who received investigational antiviral therapy within 2 weeks prior to sample collection

Trial design

60 participants in 1 patient group

HSCT Patient Group

Description:

This group includes patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT). Archived plasma samples from these patients are used to evaluate the performance of the SE-SPTM-PCR platform for detecting hcmv-miR-UL22A-5p. Each sample has a corresponding CMV DNA test result, which serves as the reference standard for assessing the diagnostic accuracy of the microRNA-based detection method.

Treatment:

Diagnostic Test: SE-SPTM-PCR microRNA assay