{ "FullStudy":{ "Rank":217882, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515605", "OrgStudyIdInfo":{ "OrgStudyId":"MoMoTxRes" }, "Organization":{ "OrgFullName":"Odense University Hospital", "OrgClass":"OTHER" }, "BriefTitle":"Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation", "OfficialTitle":"Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation", "Acronym":"MoMoTxRes" }, "StatusModule":{ "StatusVerifiedDate":"September 2019", "OverallStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2023", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"December 2023", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 6, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 9, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Martin Tepel", "ResponsiblePartyInvestigatorTitle":"Dr", "ResponsiblePartyInvestigatorAffiliation":"Odense University Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Odense University Hospital", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or tissue from patients after kidney transplantation. In the present study the investigators examine the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after transplantation.\n\nRoutine clinical and laboratory data from serum and urine are evaluated at baseline and after 0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase), TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3), MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques. Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected genes are analyzed using standard techniques. Data are analyzed by descriptive statistics. Differences between groups were analyzed using Mann-Whitney test or Kruskal-Wallis-test and Dunn`s multiple comparison post-test, as appropriate. Associations between variables are analyzed using regression analyses. Contingency tables are analyzed using Fisher's exact test.", "DetailedDescription":"Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or tissue from recipients after kidney transplantation and donors. In the present study the investigators examine the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after transplantation.\n\nRoutine clinical and laboratory data from serum and urine are evaluated at baseline and after 0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years, after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase), TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3), MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques. Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected genes are analyzed using standard techniques." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Transplantation Infection", "Kidney Diseases" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "BioSpec":{ "BioSpecRetention":"Samples With DNA", "BioSpecDescription":"Blood, urine, tissue" }, "EnrollmentInfo":{ "EnrollmentCount":"1000", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Patients after kidney transplantation", "ArmGroupDescription":"Patients after kidney transplantation" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Cellular transcripts", "PrimaryOutcomeDescription":"Transcripts and protein", "PrimaryOutcomeTimeFrame":"Day1" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Cellular transcripts", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day8" },{ "SecondaryOutcomeMeasure":"Cellular transcripts", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day15" },{ "SecondaryOutcomeMeasure":"Cellular transcripts", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day22" },{ "SecondaryOutcomeMeasure":"Cellular transcripts", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day29" },{ "SecondaryOutcomeMeasure":"Plasma proteome", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day1" },{ "SecondaryOutcomeMeasure":"Plasma proteome", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day8" },{ "SecondaryOutcomeMeasure":"Plasma proteome", "SecondaryOutcomeTimeFrame":"Day15" },{ "SecondaryOutcomeMeasure":"Plasma proteome", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day22" },{ "SecondaryOutcomeMeasure":"Plasma proteome", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day29" },{ "SecondaryOutcomeMeasure":"Urine proteome", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day1" },{ "SecondaryOutcomeMeasure":"Urine proteome", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day8" },{ "SecondaryOutcomeMeasure":"Urine proteome", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day15" },{ "SecondaryOutcomeMeasure":"Urine proteome", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day22" },{ "SecondaryOutcomeMeasure":"Urine proteome", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day29" },{ "SecondaryOutcomeMeasure":"Association of measures with glomerular filtration rate", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Day29" },{ "SecondaryOutcomeMeasure":"Association of measures with glomerular filtration rate", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Month6" },{ "SecondaryOutcomeMeasure":"Association of measures with glomerular filtration rate", "SecondaryOutcomeDescription":"Transcripts and protein", "SecondaryOutcomeTimeFrame":"Month12" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients after kidney transplantation, male, female, informed consent\n\nExclusion Criteria:\n\nDeny of informed consent", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Kidney transplantation", "SamplingMethod":"Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Martin Tepel, Dr", "OverallOfficialAffiliation":"Odense University Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Odense University Hospital", "LocationStatus":"Recruiting", "LocationCity":"Odense", "LocationState":"DK", "LocationZip":"5000", "LocationCountry":"Denmark", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Martin Tepel, Dr", "LocationContactRole":"Contact", "LocationContactPhone":"4565503755", "LocationContactEMail":"mtepel@health.sdu.dk" },{ "LocationContactName":"Martin Tepel, Dr", "LocationContactRole":"Contact", "LocationContactPhone":"4565503755", "LocationContactEMail":"martin.tepel@rsyd.dk" },{ "LocationContactName":"Martin Tepel, Dr", "LocationContactRole":"Principal Investigator" } ] } } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007674", "ConditionMeshTerm":"Kidney Diseases" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000014570", "ConditionAncestorTerm":"Urologic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9281", "ConditionBrowseLeafName":"Kidney Diseases", "ConditionBrowseLeafAsFound":"Kidney Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15902", "ConditionBrowseLeafName":"Urologic Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" } ] } } } } } }