Nctid:
NCT06225206
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21960", "name"=>"Sirolimus", "relevance"=>"LOW"}, {"id"=>"M12128", "name"=>"Mycophenolic Acid", "relevance"=>"LOW"}, {"id"=>"M18950", "name"=>"Tacrolimus", "relevance"=>"LOW"}, {"id"=>"M14121", "name"=>"Prednisone", "relevance"=>"LOW"}, {"id"=>"M18961", "name"=>"Cyclosporine", "relevance"=>"LOW"}, {"id"=>"M6730", "name"=>"Cyclosporins", "relevance"=>"LOW"}, {"id"=>"M11110", "name"=>"Liver Extracts", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"OTHER", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>300}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2021-07-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-26", "studyFirstSubmitDate"=>"2023-11-13", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"dd-cfDNA range in liver transplant patients", "timeFrame"=>"1 year", "description"=>"Determine the dd-cfDNA in liver transplant patients with stable IS collected from July 2021 to July 2024 and compare the range between patients with \\<1-year post-transplant (PTX) and \\>1-year PTX by chart review using Methodist hospital data system."}], "secondaryOutcomes"=>[{"measure"=>"Demographics: age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)", "timeFrame"=>"1 year", "description"=>"Demographics differences in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX"}, {"measure"=>"Days post-transplant at first dd-cfDNA", "timeFrame"=>"1 year", "description"=>"Number of days post transplant at first dd-cfDNA"}, {"measure"=>"LFTs: Alanine transaminase(ALT), Aspartate transaminase(AST),Alkaline phosphatase( ALP), total bilirubin (Tbili)", "timeFrame"=>"1 year", "description"=>"looking at the liver function tests in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX"}, {"measure"=>"Serum Creatinine", "timeFrame"=>"1 year", "description"=>"Measuring the serum creatinine levels"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Liver Transplant Failure"]}, "descriptionModule"=>{"briefSummary"=>"Determine the levels of Donor-derived (dd)cell-free DNA(cfDNA )in liver transplant recipients with normal liver function tests (LFTs) indicating stable immunosuppression status (IS). Based on this range use the dd-cfDNA levels to determine over or under IS in liver transplant patients to make changes to their IS medication regimen.", "detailedDescription"=>"dd-cfDNA is a non-invasive method to measure graft function stability in liver transplant patients. Liver biopsy is the standard to determine liver rejection and graft function, but no tests exist currently to be able to help guide the IS regimen in these patients. LFTs are not as specific to determine graft function hence testing dd-cfDNA levels can help guide the Immunosuppression (IS )medications dosing and help identify rejection early."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Patients included in the study should be at least 18 years of age, who have underwent a liver transplant and at least have one level of dd-cfDNA documented.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age: ≥18 years\n2. The patient underwent a liver transplant.\n3. The patient at least has one level of dd-cfDNA documented\n\nExclusion Criteria:\n\n* Patient not meeting the inclusion criteria will be excluded."}, "identificationModule"=>{"nctId"=>"NCT06225206", "briefTitle"=>"Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"Methodist Health System"}, "officialTitle"=>"Retrospective Exploratory Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients", "orgStudyIdInfo"=>{"id"=>"023.HEP.2023.D"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"donor-derived cell free DNA in liver", "type"=>"BEHAVIORAL", "description"=>"Determine the difference in age, gender, LFTs, IS regimen (tacrolimus/sirolimus/cyclosporin with mycophenolate mofetil (MMF) and /or prednisone) between patients who underwent liver transplant \\<1 year PTX and \\>1 year PTX"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75203", "city"=>"Dallas", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Methodist Dallas Medical Center", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}], "centralContacts"=>[{"name"=>"Kavya Vinod Mankulangara, PharmD", "role"=>"CONTACT", "email"=>"MHSIRB@mhd.com", "phone"=>"214-947-4681"}, {"name"=>"Bethany Brauer, MPH", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-4681"}], "overallOfficials"=>[{"name"=>"Parvez Mantry, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Methodist Midlothian Medical Center"}]}, "ipdSharingStatementModule"=>{"timeFrame"=>"2 years", "ipdSharing"=>"YES", "description"=>"Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Methodist Health System", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
