MedTrace Logo

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

NCT07181330 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Infections
  • Hematopoietic Stem Cell Transplantation (HSCT)
  • CMV Reactivation
  • ALLOGENEIC 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.

Sponsors & Collaborators

  • Ting YANG

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2021-05-06
Completion
2025-06-18

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07181330 on ClinicalTrials.gov