[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583457":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":10,"locations":25,"responsibleParty":62,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":10,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":10,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":10,"overallStatus":79,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Invivoscribe, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"T-Cell Positive Lymphoproliferative Disorders",null,"FFPE Samples for subjects with T-Cell Positive Lymphoproliferative Disorders",[13],"Diagnostic Test: IdentiClone Dx TRG Assay",{"label":15,"type":10,"description":15,"interventionNames":16},"FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","IdentiClone Dx TRG Assay","The IdentiClone Dx TRG Assay (\"Assay\") is an in vitro diagnostic product intended for qualitative capillary electrophoresis based-detection of clonality in T-cell receptor gamma chain (TRG) gene rearrangements in Formalin-Fixed Paraffin-Embedded (FFPE) specimens as an adjunctive method for the diagnosis of T-cell lymphoproliferative disease. This qualitative, non-automated Assay is for use on the ABI 3500xL Dx and ABI 3500xL Genetic Analyzers.",[15,9],[24],"IdentiClone Dx IGH (IC IGH Dx) Assay",[26,38,49],{"facility":5,"status":10,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":10},"San Diego","California","92103","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-117.16472,32.71571,{"lat":36,"lon":35},{"facility":39,"status":10,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":48,"contacts":10},"LabPMM GmbH","Hallbergmoos","85399","Germany","DE",{"type":33,"coordinates":45},[46,47],11.75142,48.32747,{"lat":47,"lon":46},{"facility":50,"status":10,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":10,"geoPoint":10,"contacts":56},"LabPMM GK","Kawasaki-shi","Kanagawa","210-0821","Japan","JP",[57],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":61},"Masato Sasaki","CONTACT","+81 80 9076 7063","msasaki@labpmm.co.jp",{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100583457","pivotal-clinical-study-for-the-accuracy-evaluation-of-the-identiclone-dx-trg-assay-100583457",false,"NCT06876571","Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay","Inclusion Criteria:\n\n1. De-identified, residual FFPE specimens with a minimum of 8 curls\n2. Subject Age ≥ 18\n3. For suspected clonal positive specimens, FFPE specimens of subjects diagnosed (at the time the specimen was drawn) with T-cell Lymphoproliferative disease with at least one of the following:\n\n   1. ICD10 Codes: C84, C85.8, C85.9, C86.1, C86.2, C86.3, C86.5, 86.6, C91.5, C91.6, C91.0, C91.z, C91.9, C94, C95, C96, or other T-cell lymphoma diagnosis\n   2. b. T-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., SNOMED)\n   3. Mycosis fungoides or Sézary syndrome sample are acceptable\n4. For suspected clonal negative specimens, FFPE specimens of subjects suspected of T-cell lymphoproliferative disease but diagnosed negative for T-cell lymphoproliferative disease. Up to 20% of the negative specimens may be from normal tissue or tissue diagnosed with diseases other than T-cell lymphoproliferative disease\n\nExclusion Criteria:\n\n1.FFPE specimens that were fixed using formalin substitute (ethanol, methanol, etc.)","ALL","18 Years",{"count":73,"type":74},250,"ESTIMATED","OBSERVATIONAL","This protocol describes the pivotal accuracy study for the IdentiClone Dx TRG Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC TRG Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from FFPE (Formalin Fixed Paraffin Embedded) samples from individuals with suspected T-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx TRG (FR1\u002FFR2\u002FFR3) Assays - MiSeq (LT Dx TRG-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC TRG Assay on the same sample type.",[78],"T-Cell Lymphoproliferative Disorder","NOT_YET_RECRUITING","2025-03-10",{"date":82,"type":83},"2025-03-14","ACTUAL",{"date":85,"type":74},"2025-06-02",{"date":87,"type":74},"2025-12-06",{"name":5,"class":6},3]