HCMV-miRNA Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation Using PSTM-qPCR

NCT07210242 | Not Yet Recruiting

• 2 other identifiers: HSCT-HCMV01FJMU(2025)648
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Human cytomegalovirus (HCMV) infection is one of the most common and serious complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Standard monitoring uses HCMV DNA testing, but this method may not detect the virus early enough to guide timely treatment. This multicenter observational study will evaluate a new high-performance microRNA (miRNA) detection technology (PSTM-qPCR) for monitoring HCMV infection in allo-HSCT patients. Approximately 300 patients and their donors will be enrolled across several major transplant centers in China. Blood samples will be collected before and after transplantation to test for both HCMV-miRNA and HCMV-DNA. The study will compare the sensitivity and timing of miRNA detection with conventional DNA testing and explore whether miRNA can serve as an early biomarker of infection and related complications. The goal is to improve early diagnosis and management of HCMV infection, reduce infection-related complications, and ultimately improve survival outcomes in patients undergoing allo-HSCT.

Conditions

Cytomegalovirus Infections; Hematopoietic Stem Cell Transplantation; Virus Reactivation; Graft vs Host Disease

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation; Human Cytomegalovirus; MicroRNA; HCMV-miRNA; PSTM-qPCR; Viral Reactivation; Infection Monitoring; Early Diagnosis; Biomarker; GVHD

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of HCMV-miRNA compared with HCMV-DNA

  Evaluate the diagnostic accuracy of HCMV-miRNA detection (using PSTM-qPCR) compared with conventional HCMV-DNA testing for early identification of cytomegalovirus infection or reactivation in allo-HSCT recipients. Outcome measures include sensitivity, specificity, and time to first positive result.

  From pre-conditioning (baseline, before allo-HSCT) through 12 months post-transplantation

Study Arms (1)

Allo-HSCT Recipients and Donors

Participants are patients scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), with stem cell sources including peripheral blood stem cells and/or bone marrow plus peripheral blood. All participants must voluntarily join the study, be able to understand study procedures, and provide written informed consent. This is an observational cohort with no experimental intervention. Participants will receive standard of care treatment for allo-HSCT. Blood samples (whole blood and plasma) will be collected before conditioning, during transplantation, and regularly after transplantation (weekly in months 1-3, monthly in months 4-6, and as clinically indicated up to 12 months). HCMV-miRNA and HCMV-DNA will be tested using PSTM-qPCR and conventional qPCR, respectively. Clinical outcomes such as HCMV infection/reactivation, GVHD, survival, and infection-related complications will be monitored.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include patients scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) at participating transplant centers in China, along with their corresponding stem cell donors. Eligible recipients are patients with hematologic malignancies or related disorders who meet transplant indications. Stem cell sources include peripheral blood stem cells and/or bone marrow plus peripheral blood. All participants must voluntarily join the study and provide written informed consent.

You may qualify if:

• \- Patients scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
• Stem cell source includes peripheral blood stem cells and/or bone marrow plus peripheral blood.
• Ability to understand study procedures and provide written informed consent.
• Voluntary participation in the study.

You may not qualify if:

• Pregnant or breastfeeding women.
• Children or individuals with severe cognitive impairment who cannot comply with blood sample collection.
• Patients with severe comorbidities or other medical conditions judged by the investigator to significantly interfere with study participation or follow-up.
• Withdrawal of informed consent during the study.
• Clinical background or history that may introduce significant confounding effects, or when additional sampling frequency is deemed to pose undue risk to the participant.

Sponsors & Collaborators

• Ting YANG: lead
• First Affiliated Hospital of Fujian Medical University: collaborator
• Xiamen University: collaborator

Related Publications (5)

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• Lyons MS, Kunnathur VA, Rouster SD, Hart KW, Sperling MI, Fichtenbaum CJ, Sherman KE. Prevalence of Diagnosed and Undiagnosed Hepatitis C in a Midwestern Urban Emergency Department. Clin Infect Dis. 2016 May 1;62(9):1066-71. doi: 10.1093/cid/ciw073. Epub 2016 Feb 21.

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• Li L, Liu Y, Chen Y, Zhai W, Dai Z. Research progress on layered metal oxide electrocatalysts for an efficient oxygen evolution reaction. Dalton Trans. 2024 May 28;53(21):8872-8886. doi: 10.1039/d4dt00619d.

  PMID: 38738345 BACKGROUND

• Melnik S, Gabler J, Dreher SI, Hecht N, Hofmann N, Grossner T, Richter W. MiR-218 affects hypertrophic differentiation of human mesenchymal stromal cells during chondrogenesis via targeting RUNX2, MEF2C, and COL10A1. Stem Cell Res Ther. 2020 Dec 10;11(1):532. doi: 10.1186/s13287-020-02026-6.

  PMID: 33303006 BACKGROUND

Related Links

• National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Xiamen University (Collaborator, central laboratory for HCMV-miRNA testing).
• European Conference on Infections in Leukaemia (ECIL) official site, providing international guidelines on CMV management in HSCT.
• Chinese expert consensus on cytomegalovirus infection management in allogeneic HSCT (2022 edition, open access).

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples (10 mL EDTA-anticoagulated) will be collected from both HSCT recipients and their donors. Whole blood and separated plasma will be retained for HCMV-miRNA and HCMV-DNA testing. In addition, residual hematopoietic stem cell samples from donors will be preserved. All samples will be stored at -20°C or below and shipped on dry ice to the central laboratory at Xiamen University (National Institute of Diagnostics and Vaccine Development in Infectious Diseases) for unified testing and analysis.

MeSH Terms

Conditions

Cytomegalovirus Infections; Graft vs Host Disease; Disease

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Department of Hematology, Fujian Medical University First Affiliated Hospital

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): October 10, 2028
• Study Completion (Estimated): October 10, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share