[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609106":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":12,"collaborators":16,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":27,"eligibilityCriteria":28,"healthyVolunteers":29,"sex":30,"minAge":10,"maxAge":10,"enrollmentInfo":31,"targetDuration":34,"studyType":35,"phases":10,"briefSummary":36,"conditions":37,"keywords":42,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":10},{"fullName":5,"class":6},"Fujian Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Allo-HSCT Recipients and Donors",null,"Participants are patients scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), with stem cell sources including peripheral blood stem cells and\u002For bone marrow plus peripheral blood. All participants must voluntarily join the study, be able to understand study procedures, and provide written informed consent.\n\nThis 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\u002Freactivation, GVHD, survival, and infection-related complications will be monitored.",{"type":13,"investigatorFullName":14,"investigatorTitle":15,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Ting YANG","Chief Physician, Department of Hematology, Fujian Medical University First Affiliated Hospital",[17,19],{"name":18,"class":6},"First Affiliated Hospital of Fujian Medical University",{"name":20,"class":6},"Xiamen University","100609106","hcmv-mirna-monitoring-after-allogeneic-hematopoietic-stem-cell-transplantation-using-pstm-qpcr-100609106",false,"NCT07210242","HCMV-miRNA Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation Using PSTM-qPCR","Clinical Study on Monitoring Cytomegalovirus (HCMV) Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Using High-Performance miRNA Quantification Technology (PSTM-qPCR)","HSCT-HCMV01","Inclusion Criteria:\n\n\\- Patients scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nStem cell source includes peripheral blood stem cells and\u002For bone marrow plus peripheral blood.\n\nAbility to understand study procedures and provide written informed consent.\n\nVoluntary participation in the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n\nChildren or individuals with severe cognitive impairment who cannot comply with blood sample collection.\n\nPatients with severe comorbidities or other medical conditions judged by the investigator to significantly interfere with study participation or follow-up.\n\nWithdrawal of informed consent during the study.\n\nClinical background or history that may introduce significant confounding effects, or when additional sampling frequency is deemed to pose undue risk to the participant.",true,"ALL",{"count":32,"type":33},300,"ESTIMATED","12 Months","OBSERVATIONAL","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.\n\nThis 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.\n\nThe 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.",[38,39,40,41],"Cytomegalovirus Infections","Hematopoietic Stem Cell Transplantation","Virus Reactivation","Graft vs Host Disease",[43,44,45,46,47,48,49,50,51,52],"Allogeneic Hematopoietic Stem Cell Transplantation","Human Cytomegalovirus","MicroRNA","HCMV-miRNA","PSTM-qPCR","Viral Reactivation","Infection Monitoring","Early Diagnosis","Biomarker","GVHD","NOT_YET_RECRUITING","2025-09-29",{"date":56,"type":57},"2025-10-07","ACTUAL",{"date":59,"type":33},"2025-10-10",{"date":61,"type":33},"2028-10-10",{"name":14,"class":6}]