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

NCT ID: NCT07181330

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2025-06-18

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

HSCT Patient Group

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.

SE-SPTM-PCR microRNA assay

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

SE-SPTM-PCR; Selective Enrichment and Specific Probe Terminal Mediated PCR; hcmv-miR-UL22A-5p assay; microRNA-based CMV test; HSCT CMV miRNA detection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ting YANG

OTHER

Sponsor Role: lead

Responsible Party

Ting YANG

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Countries

China

Other Identifiers

FMU-XMU-SESPTM-01

Identifier Type: -

Identifier Source: org_study_id