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

NCT07181330 | Completed

• 1 other identifier: FMU-XMU-SESPTM-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cytomegalovirus; hcmv-miR-UL22A-5p; CMV reactivation; microRNA biomarker; miRNA detection; SE-SPTM-PCR; Hematopoietic Stem Cell Transplantation; Allogeneic HSCT; Liquid biopsy; Retrospective study; qPCR; Viral monitoring; Transplant infection

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of SE-SPTM-PCR for detecting CMV reactivation

  The primary outcome is the area under the receiver operating characteristic (ROC) curve (AUC) of SE-SPTM-PCR detection of hcmv-miR-UL22A-5p in plasma, compared to CMV DNA qPCR as the reference standard. Sensitivity and specificity will also be assessed.

  through study completion, an average of 1 month

Study Arms (1)

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.

Diagnostic Test: SE-SPTM-PCR microRNA assay

Interventions

SE-SPTM-PCR microRNA assay 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.

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

HSCT Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) and had archived plasma samples collected within 100 days after transplantation. All participants had corresponding cytomegalovirus (CMV) DNA testing results available. Samples were retrospectively analyzed to assess the diagnostic performance of hcmv-miR-UL22A-5p using the SE-SPTM-PCR platform.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ting YANG: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Archived human plasma samples will be retained for analysis. The samples were collected from patients who underwent allogeneic hematopoietic stem cell transplantation. Each sample contains circulating RNA, including viral microRNAs such as hcmv-miR-UL22A-5p. All specimens are de-identified and stored in a coded format.

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 18, 2025
• Study Start: May 6, 2021
• Primary Completion: May 6, 2021
• Study Completion: June 18, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)