[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493715":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":36,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":36,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":36,"overallStatus":49,"whyStopped":36,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lung Transplant Recipients","EXPERIMENTAL","Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded.",[13,14,15],"Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)","Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay","Drug: Valganciclovir",[17,24,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)","Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).",[9],[23],"Viracor inSIGHT",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DIAGNOSTIC_TEST","Donor-Derived Cell-Free DNA (dd-cfDNA) Assay","Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.",[9],[30],"Viracor TRAC",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Valganciclovir","Delivered as standard of care for post-lung transplant immunosuppression and infection prophylaxis. Started on the first day post-transplant at a standard dose of 900 mg daily and continued for 12 months. Dose adjustments may be necessary based on renal function and\u002For adverse effects (e.g. neutropenia). Dose adjustments are standard based on package insert recommendations.",[9],null,[38],{"name":39,"affiliation":5,"role":40},"Luis Angel, MD","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":36,"email":46},"Tyler Lewis","CONTACT","866-838-5864","Tyler.lewis@nyulangone.org",[48],{"facility":5,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","New York","10016","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-74.00597,40.71427,{"lat":58,"lon":57},[61],{"name":43,"role":44,"phone":45,"phoneExt":36,"email":46},{"type":63,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[65],{"name":66,"class":67},"Viracor Eurofins","UNKNOWN","100493715","phase-2-cmv-immunity-monitoring-in-lung-transplant-recipients-100493715",false,"NCT05708755","CMV Immunity Monitoring in Lung Transplant Recipients","Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients","Inclusion Criteria:\n\n1. Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health\n2. Pre-existing serological immunity to CMV (R+)\n3. Able and willing to provide informed consent\n\nExclusion Criteria:\n\n1. Anti-thymocyte globulin induction immunosuppression\n2. Perioperative desensitization\n3. Pregnant or breastfeeding women","ALL","18 Years","99 Years",{"count":79,"type":80},50,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.",[86],"Lung Transplant; Complications","2026-05-27",{"date":89,"type":90},"2026-05-29","ACTUAL",{"date":92,"type":90},"2024-09-13",{"date":94,"type":80},"2028-05",{"name":5,"class":6},1]