[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597609":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":26,"responsibleParty":178,"collaborators":7,"id":180,"slug":7,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":7,"eligibilityCriteria":185,"healthyVolunteers":181,"sex":186,"minAge":187,"maxAge":7,"enrollmentInfo":188,"targetDuration":7,"studyType":191,"phases":7,"briefSummary":192,"conditions":193,"keywords":7,"overallStatus":42,"whyStopped":7,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"Insight Molecular Diagnostics","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","donor-derived cell-free DNA test","A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.",[14],{"name":15,"affiliation":5,"role":16},"Ekkehard Schuetz, MD, PhD","STUDY_CHAIR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":7,"email":22},"Robert Rogers, M.S.","CONTACT","14436258427","rrogers@imdxinc.com",{"name":15,"role":20,"phone":24,"phoneExt":7,"email":25},"615-927-1528","eschuetz@imdxinc.com",[27,40,59,78,95,105,122,141,158,169],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":7},"University of Southern California Keck School of Medicine","ACTIVE_NOT_RECRUITING","Los Angeles","California","90033","United States",{"type":35,"coordinates":36},"Point",[37,38],-118.24368,34.05223,{"lat":38,"lon":37},{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":33,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"Mayo Clinic in Florida","RECRUITING","Jacksonville","Florida","32224",{"type":35,"coordinates":47},[48,49],-81.65565,30.33218,{"lat":49,"lon":48},[52,56],{"name":53,"role":20,"phone":54,"phoneExt":7,"email":55},"Carla Palmucci","904-953-3182","Palmucci.Carla@mayo.edu",{"name":57,"role":58,"phone":7,"phoneExt":7,"email":7},"Mohamed Elrefaei, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":42,"city":61,"state":44,"zip":62,"country":33,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Tampa General Hospital","Tampa","33606",{"type":35,"coordinates":64},[65,66],-82.45843,27.94752,{"lat":66,"lon":65},[69,73,76],{"name":70,"role":20,"phone":71,"phoneExt":7,"email":72},"Anelys Marin, B.S.","813-844-2673","research@tgh.org",{"name":74,"role":20,"phone":7,"phoneExt":7,"email":75},"Sandra Sanchez","slsanchez@tgh.org",{"name":77,"role":58,"phone":7,"phoneExt":7,"email":7},"Suzane Gilbert, 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McAllister","214-820-1710","Ashley.McAllister@BSWHealth.org",{"facility":142,"status":42,"city":143,"state":144,"zip":145,"country":33,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Intermountain Health","Murray","Utah","84107",{"type":35,"coordinates":147},[148,149],-111.88799,40.66689,{"lat":149,"lon":148},[152,156],{"name":153,"role":20,"phone":154,"phoneExt":7,"email":155},"Shannon Sell","801-507-8390","Shannon.sell@imail.org",{"name":157,"role":58,"phone":7,"phoneExt":7,"email":7},"Sanjiv Anand, MD",{"facility":159,"status":29,"city":160,"state":161,"zip":162,"country":163,"cosmosGeoPoint":164,"geoPoint":168,"contacts":7},"Institute of Immunology - Transplantation Immunology","Heidelberg","Baden-Wurttemberg","69120","Germany",{"type":35,"coordinates":165},[166,167],8.69079,49.40768,{"lat":167,"lon":166},{"facility":170,"status":29,"city":171,"state":7,"zip":172,"country":163,"cosmosGeoPoint":173,"geoPoint":177,"contacts":7},"Charite Universitatsmedizin","Berlin","10117",{"type":35,"coordinates":174},[175,176],13.41053,52.52437,{"lat":176,"lon":175},{"type":179,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100597609",false,"NCT07060716","Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring","GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring","Inclusion Criteria:\n\n1. Subject is 18 years of age or older\n2. At least 12 calendar days have elapsed since the subject received a kidney transplant.\n3. Subject has provided legally effective informed consent\n4. Subject agrees to comply with all study procedures\n\nExclusion Criteria:\n\n1. Kidney donor is an identical twin of the subject.\n2. The subject has another previously transplanted organ in situ.\n3. Subject has received a hematopoietic stem cell transplant.\n4. Subject has received a bone marrow graft.\n5. Subject has self-reported as pregnant.\n6. In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.\n\nSample Inclusion Criteria:\n\n1\\. A graft biopsy is obtained within ±1 week of blood draw.\n\n* If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.\n\nSample Exclusion Criteria:\n\n1. Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.\n2. Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw\n3. Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.\n4. Sample collected from a subject that provided another sample for the study within the past 7 days.","ALL","18 Years",{"count":189,"type":190},125,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.\n\nResearchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.",[194,195],"Kidney Transplant Rejection","Cell-free DNA","2025-11-18",{"date":198,"type":199},"2025-11-19","ACTUAL",{"date":201,"type":199},"2025-09-08",{"date":203,"type":190},"2025-12",{"name":5,"class":6},10]