Cytomegalovirus InfectionsSESPTM-CMVNCT07181330
Clinical Performance of SE-SPTM-PCR in Detecting Hcmv-miR-UL22A-5p After Hematopoietic Stem Cell Transplantation
An observational study of Cytomegalovirus Infections and Hematopoietic Stem Cell Transplantation (HSCT), run by Ting YANG at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation (HSCT), CMV Reactivation
- What is being tested?
- SE-SPTM-PCR microRNA assay
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2021to 18 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350001
About this study
Official title: Retrospective Clinical Validation of the SE-SPTM-PCR Platform for Hcmv-miR-UL22A-5p Detection in Monitoring Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the 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
- Being tested
- SE-SPTM-PCR microRNA assay
- 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
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SE-SPTM-PCR microRNA assayDiagnostic test
Also called SE-SPTM-PCR, Selective Enrichment and Specific Probe Terminal Mediated PCR, hcmv-miR-UL22A-5p assay, microRNA-based CMV 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: SE-SPTM-PCR microRNA assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start6 May 2021
- Primary completion6 May 2021
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ting YANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ting YANG, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181330
- Sponsor's protocol ID
- FMU-XMU-SESPTM-01
- Acronym
- SESPTM-CMV
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Validation of the SE-SPTM-PCR Platform for Hcmv-miR-UL22A-5p Detection in Monitoring Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07181330
- Acronym / sponsor ID
- SESPTM-CMV / FMU-XMU-SESPTM-01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ting YANGUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 18 Sep 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSCT Patient Group | – | Diagnostic Test: SE-SPTM-PCR microRNA assayThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SE-SPTM-PCR microRNA assayAlso: SE-SPTM-PCR, Selective Enrichment and Specific Probe Terminal Mediated PCR, hcmv-miR-UL22A-5p assay, microRNA-based CMV testSE-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. | Diagnostic test | HSCT Patient Group |
Primary outcome
Diagnostic performance of SE-SPTM-PCR for detecting CMV reactivation
Time frame: through study completion, an average of 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections and Hematopoietic Stem Cell Transplantation (HSCT), run by Ting YANG at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 SE-SPTM-PCR for detecting CMV reactivation (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025.