[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07060716":3,"trial-entities:NCT07060716":209,"trial-summary:NCT07060716":213},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":32,"secondary_outcomes":47,"sex":54,"minimum_age":55,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":61,"locations":64,"central_contacts":195,"overall_officials":204,"references":207,"see_also_links":208},"NCT07060716","CLN-001","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","RECRUITING","2025-12","2025-11","2025-11-19","2025-09-08","Insight Molecular Diagnostics","INDUSTRY",false,"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.",null,[19,20],"Kidney Transplant Rejection","Cell-free DNA",[],"OBSERVATIONAL",[],{"count":25,"type":26},125,"ESTIMATED",[28],{"type":29,"name":30,"description":31},"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.",[33,37,40,43,45],{"measure":34,"description":35,"timeFrame":36},"Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection","Relative percentage of dd-cfDNA levels of 0.5% and absolute values of 50cp\u002FmL are considered to be the diagnostic cutoff for rejection, which will be refined during the first study phase.","Samples tested after final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 18 weeks after acquisition of the samples.",{"measure":34,"description":38,"timeFrame":39},"Clinical sensitivity of the dd-cfDNA test shall be better or equal to published values (≥56%). Current literature shows an average sensitivity of 69% with a SD of 13%. Therefore, 56% represents the lower boundary (average - 1SD) of the distribution of published values.","Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.",{"measure":34,"description":41,"timeFrame":42},"Clinical Specificity of the dd-cfDNA test shall be better or equal to published values (≥75%). Current literature shows an average specificity of 81% with a SD of 6%. Therefore, 75% represents the lower boundary (average - 1SD) of the distribution of published values.","Samples tested after the assay final cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.",{"measure":34,"description":44,"timeFrame":39},"Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for NPV is 85%.",{"measure":34,"description":46,"timeFrame":39},"Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for Positive Predictive Value (PPV) is 49%.",[48,52],{"measure":49,"description":50,"timeFrame":51},"ROC-AUC of dd-cfDNA vs. biopsy-confirmed rejection.","The second endpoint is for investigational use only and therefore has no predefined success criteria.","This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.",{"measure":53,"description":50,"timeFrame":51},"Correlation between GraftAssureDx results and traditional biomarkers of kidney rejection (creatinine, estimated glomerular filtration rate, blood urea nitrogen).","ALL","18 Years",{"inclusion":57,"exclusion":59,"raw_text":60},[58],"If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.",[],"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.",[62,63],"ADULT","OLDER_ADULT",[65,75,92,109,124,132,147,164,179,188],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"geoPoint":72},"University of Southern California Keck School of Medicine","ACTIVE_NOT_RECRUITING","Los Angeles","California","90033","United States",{"lat":73,"lon":74},34.05223,-118.24368,{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":71,"contacts":80,"geoPoint":89},"Mayo Clinic in Florida","Jacksonville","Florida","32224",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Carla Palmucci","CONTACT","904-953-3182","Palmucci.Carla@mayo.edu",{"name":87,"role":88},"Mohamed Elrefaei, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},30.33218,-81.65565,{"facility":93,"status":8,"city":94,"state":78,"zip":95,"country":71,"contacts":96,"geoPoint":106},"Tampa General Hospital","Tampa","33606",[97,101,104],{"name":98,"role":83,"phone":99,"email":100},"Anelys Marin, B.S.","813-844-2673","research@tgh.org",{"name":102,"role":83,"email":103},"Sandra Sanchez","slsanchez@tgh.org",{"name":105,"role":88},"Suzane Gilbert, MD",{"lat":107,"lon":108},27.94752,-82.45843,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":71,"contacts":114,"geoPoint":121},"Cleveland Clinic","Cleveland","Ohio","44195",[115,119],{"name":116,"role":83,"phone":117,"email":118},"Jennifer Seaman-Czerr","216-990-0436","Czerrj@ccf.org",{"name":120,"role":88},"Ziad Zaky, MD",{"lat":122,"lon":123},41.4995,-81.69541,{"facility":125,"status":67,"city":126,"state":127,"zip":128,"country":71,"geoPoint":129},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15213",{"lat":130,"lon":131},40.44062,-79.99589,{"facility":133,"status":8,"city":134,"state":135,"zip":136,"country":71,"contacts":137,"geoPoint":144},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",[138,142],{"name":139,"role":83,"phone":140,"email":141},"Keyann Reaves","615-936-0695","Keyann.d.reaves@vumc.org",{"name":143,"role":88},"Anthony Langone, MD",{"lat":145,"lon":146},36.16589,-86.78444,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":71,"contacts":152,"geoPoint":161},"Baylor, Scott & White Research Institute","Dallas","Texas","75246",[153,157],{"name":154,"role":83,"phone":155,"email":156},"Eric Javier Martinez, MD","214-820-2050","Eric.Martinez1@BSWHealth.org",{"name":158,"role":83,"phone":159,"email":160},"Ashley McAllister","214-820-1710","Ashley.McAllister@BSWHealth.org",{"lat":162,"lon":163},32.78306,-96.80667,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":71,"contacts":169,"geoPoint":176},"Intermountain Health","Murray","Utah","84107",[170,174],{"name":171,"role":83,"phone":172,"email":173},"Shannon Sell","801-507-8390","Shannon.sell@imail.org",{"name":175,"role":88},"Sanjiv Anand, MD",{"lat":177,"lon":178},40.66689,-111.88799,{"facility":180,"status":67,"city":181,"state":182,"zip":183,"country":184,"geoPoint":185},"Institute of Immunology - Transplantation Immunology","Heidelberg","Baden-Wurttemberg","69120","Germany",{"lat":186,"lon":187},49.40768,8.69079,{"facility":189,"status":67,"city":190,"zip":191,"country":184,"geoPoint":192},"Charite Universitatsmedizin","Berlin","10117",{"lat":193,"lon":194},52.52437,13.41053,[196,200],{"name":197,"role":83,"phone":198,"email":199},"Robert Rogers, M.S.","14436258427","rrogers@imdxinc.com",{"name":201,"role":83,"phone":202,"email":203},"Ekkehard Schuetz, MD, PhD","615-927-1528","eschuetz@imdxinc.com",[205],{"name":201,"affiliation":13,"role":206},"STUDY_CHAIR",[],[],{"nct_id":4,"conditions":210,"biomarkers":212},[211],"Kidney Transplantation",[],{"nct_id":4,"found":214,"summary":215,"prompt_version":225},true,{"design":216,"status":217,"heading":218,"summary":219,"follow_up":220,"word_count":221,"commitments":222,"compensation":223,"drugs_mentioned":224},"This is an observational study aiming to enroll about 125 participants. It is designed to compare the results of a new diagnostic test with standard biopsy results.","completed","Observational Study of Donor-Derived Cell-Free DNA for Kidney Transplant Monitoring","This observational study is looking at a diagnostic test called donor-derived cell-free DNA (dd-cfDNA) to see if it can help detect rejection in people who have received a kidney transplant. Researchers want to compare the results of the dd-cfDNA test to traditional kidney biopsies (where a small piece of tissue is removed for examination) to see how well the test works. You might be able to join if you are 18 or older, received a kidney transplant at least 12 days ago, and agree to follow study procedures. The study aims to enroll about 125 participants. The current recruitment status is unclear.","Samples will be analyzed for clinical performance from enrollment up to 24 weeks after they are acquired.",102,"You would have blood and urine collected at your study visit. The study will analyze samples collected from enrollment up to 24 weeks after they are acquired.","Not stated in the trial record.",[],"v2"]