Cytomegalovirus InfectionsHSCT-HCMV01NCT07210242
HCMV-miRNA Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation Using PSTM-qPCR
An observational study of Cytomegalovirus Infections and Hematopoietic Stem Cell Transplantation, run by Ting YANG.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation, Virus Reactivation
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2025to 10 Oct 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Clinical Study on Monitoring Cytomegalovirus (HCMV) Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Using High-Performance miRNA Quantification Technology (PSTM-qPCR)
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.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for hematologic malignancies and non-malignant disorders. However, post-transplant immune suppression and delayed immune reconstitution make patients highly susceptible to opportunistic infections, among which human cytomegalovirus (HCMV) infection and reactivation are the most frequent and clinically significant. HCMV reactivation has been associated with increased non-relapse mortality, graft-versus-host disease (GVHD), marrow suppression, and organ-specific disease, significantly affecting patient outcomes.
Current standard monitoring relies on quantitative polymerase chain reaction (qPCR)-based HCMV DNA testing in peripheral blood. While this method has improved patient management, limitations remain. HCMV DNA testing may lack sufficient sensitivity to detect early viral reactivation, leading to missed opportunities for timely pre-emptive therapy. Increasing evidence suggests that HCMV-encoded microRNAs (miRNAs), which play critical roles in viral latency, replication, and immune evasion, may serve as novel biomarkers for earlier detection of HCMV activity.
This prospective, multicenter, observational cohort study will evaluate the diagnostic and predictive performance of HCMV-miRNAs using a novel high-performance detection platform, PSTM-qPCR, developed in collaboration with the National Institute of Diagnostics and Vaccine Development in Infectious Diseases at Xiamen University. PSTM-qPCR offers markedly improved sensitivity and specificity compared with conventional qPCR, with the ability to distinguish single-base differences and detect viral activity earlier.
Approximately 300 allo-HSCT recipients and their donors will be enrolled across seven transplant centers in China. Blood samples will be collected at baseline (pre-transplant) and serially post-transplant (weekly during the first 3 months, monthly through 6 months, and as clinically indicated up to 12 months). Both HCMV-miRNA and HCMV-DNA will be measured. Primary outcome measures include the diagnostic performance of HCMV-miRNA compared with HCMV-DNA for early detection of HCMV infection. Secondary outcomes include rates of HCMV infection and reactivation, HCMV-related mortality and organ disease, GVHD incidence, and overall survival.
The study aims to validate HCMV-miRNA as a reliable early biomarker for HCMV infection in allo-HSCT recipients. By establishing a sensitive and clinically applicable monitoring strategy, this research seeks to improve infection control, guide individualized antiviral therapy, and ultimately enhance survival and quality of life in transplant patients.
- 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
- Medical subject headings
- Cytomegalovirus Infections, Graft vs Host Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From pre-conditioning (baseline, before allo-HSCT) through 12 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start10 Oct 2025 (estimated)
- Primary completion10 Oct 2028 (estimated)
- Study completion10 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ting YANG
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Xiamen University
- Responsible party
- Sponsor-investigator, Ting YANG, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210242
- Sponsor's protocol ID
- HSCT-HCMV01
- Other IDs
- FJMU(2025)648
- Acronym
- HSCT-HCMV01
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy concerns and ethical restrictions. Only de-identified, aggregated results will be published in scientific journals or presented at academic conferences.
Publications
Toyooka S, Ito M, Kakinuma A, Kayama S, Watanabe K, Miyamoto W, Nakagawa T, Kawano H. Periarticular multimodal drug injection does not improves early postoperative analgesia compared with continuous interscalene brachial plexus block after arthroscopic rotator cuff repair: A retrospective single-center comparative study. J Orthop Sci. 2020 May;25(3):405-409. doi: 10.1016/j.jos.2019.04.013. Epub 2019 May 29.
PubMed 31153741Pujari A, Kumar S, Markan A, Chawla R, Damodaran S, Kumar A. Buckling surgery on a goat's eye: A simple technique to enhance residents' surgical skill. Indian J Ophthalmol. 2019 Aug;67(8):1327-1328. doi: 10.4103/ijo.IJO_1779_18.
PubMed 31332123Lyons 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.
PubMed 26908799Li 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.
PubMed 38738345Melnik 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.
PubMed 33303006
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Monitoring Cytomegalovirus (HCMV) Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Using High-Performance miRNA Quantification Technology (PSTM-qPCR)
- ClinicalTrials.gov ID
- NCT07210242
- Acronym / sponsor ID
- HSCT-HCMV01 / HSCT-HCMV01
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ting YANGUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Xiamen University
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 10 Oct 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for hematologic malignancies and non-malignant disorders. However, post-transplant immune suppression and delayed immune reconstitution make patients highly susceptible to opportunistic infections, among which human cytomegalovirus (HCMV) infection and reactivation are the most frequent and clinically significant. HCMV reactivation has been associated with increased non-relapse mortality, graft-versus-host disease (GVHD), marrow suppression, and organ-specific disease, significantly affecting patient outcomes.
Current standard monitoring relies on quantitative polymerase chain reaction (qPCR)-based HCMV DNA testing in peripheral blood. While this method has improved patient management, limitations remain. HCMV DNA testing may lack sufficient sensitivity to detect early viral reactivation, leading to missed opportunities for timely pre-emptive therapy. Increasing evidence suggests that HCMV-encoded microRNAs (miRNAs), which play critical roles in viral latency, replication, and immune evasion, may serve as novel biomarkers for earlier detection of HCMV activity.
This prospective, multicenter, observational cohort study will evaluate the diagnostic and predictive performance of HCMV-miRNAs using a novel high-performance detection platform, PSTM-qPCR, developed in collaboration with the National Institute of Diagnostics and Vaccine Development in Infectious Diseases at Xiamen University. PSTM-qPCR offers markedly improved sensitivity and specificity compared with conventional qPCR, with the ability to distinguish single-base differences and detect viral activity earlier.
Approximately 300 allo-HSCT recipients and their donors will be enrolled across seven transplant centers in China. Blood samples will be collected at baseline (pre-transplant) and serially post-transplant (weekly during the first 3 months, monthly through 6 months, and as clinically indicated up to 12 months). Both HCMV-miRNA and HCMV-DNA will be measured. Primary outcome measures include the diagnostic performance of HCMV-miRNA compared with HCMV-DNA for early detection of HCMV infection. Secondary outcomes include rates of HCMV infection and reactivation, HCMV-related mortality and organ disease, GVHD incidence, and overall survival.
The study aims to validate HCMV-miRNA as a reliable early biomarker for HCMV infection in allo-HSCT recipients. By establishing a sensitive and clinically applicable monitoring strategy, this research seeks to improve infection control, guide individualized antiviral therapy, and ultimately enhance survival and quality of life in transplant patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of HCMV-miRNA compared with HCMV-DNA
Time frame: From pre-conditioning (baseline, before allo-HSCT) through 12 months post-transplantation
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Background: PubMed 31153741Toyooka S, Ito M, Kakinuma A, Kayama S, Watanabe K, Miyamoto W, Nakagawa T, Kawano H. Periarticular multimodal drug injection does not improves early postoperative analgesia compared with continuous interscalene brachial plexus block after arthroscopic rotator cuff repair: A retrospective single-center comparative study. J Orthop Sci. 2020 May;25(3):405-409. doi: 10.1016/j.jos.2019.04.013. Epub 2019 May 29.
- Background: PubMed 31332123Pujari A, Kumar S, Markan A, Chawla R, Damodaran S, Kumar A. Buckling surgery on a goat's eye: A simple technique to enhance residents' surgical skill. Indian J Ophthalmol. 2019 Aug;67(8):1327-1328. doi: 10.4103/ijo.IJO_1779_18.
- Background: PubMed 26908799Lyons 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.
- Background: PubMed 38738345Li 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.
- Background: PubMed 33303006Melnik 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.
- National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Xiamen University (Collaborator, central laboratory for HCMV-miRNA testing).Link provided by the sponsor.
- European Conference on Infections in Leukaemia (ECIL) official site, providing international guidelines on CMV management in HSCT.Link provided by the sponsor.
- Chinese expert consensus on cytomegalovirus infection management in allogeneic HSCT (2022 edition, open access).Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy concerns and ethical restrictions. Only de-identified, aggregated results will be published in scientific journals or presented at academic conferences.
Related trials for Cytomegalovirus Infections
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections and Hematopoietic Stem Cell Transplantation, run by Ting YANG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of HCMV-miRNA compared with HCMV-DNA (time frame: From pre-conditioning (baseline, before allo-HSCT) through 12 months post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210242, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.