[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Invivoscribe, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100533157","the-use-of-residual-de-identified-specimens-andor-samples-from-patients-for-clinical-research-100533157",false,"NCT06222164","The Use of Residual De-identified Specimens and\u002For Samples From Patients for Clinical Research","Inclusion Criteria:\n\n1. Specimen\u002Fsample, peripheral blood (PB), bone marrow (BM), genomic DNA (gDNA) and\u002For formalin-fixed paraffin-embedded tissue (FFPE) from patients whose specimens\u002Fsamples have been sent to LabPMM for clinical testing\n2. Donor Age ≥ 18 years\n\nExclusion Criteria:\n\n1. Sample\u002Fspecimen has been obtained from a third-party vendor with a Materials Transfer Agreement (MTA) on file with LabPMM\n2. The specimens\u002Fsamples have previously been enrolled in a clinical study","ALL","18 Years",{"count":18,"type":19},2000,"ESTIMATED","OBSERVATIONAL","Acquire residual human specimens and\u002For samples from patient samples which were sent for testing at LabPMM, LLC for Clinical Research",[23],"Hematologic Diseases",[25],"residual samples hematologic diseases","RECRUITING","2025-05-02",{"date":29,"type":30},"2025-05-04","ACTUAL",{"date":32,"type":30},"2024-03-30",{"date":34,"type":19},"2027-06-30",{"name":36,"class":37},"Invivoscribe, Inc.","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":47,"conditions":48,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":59},"100583457","pivotal-clinical-study-for-the-accuracy-evaluation-of-the-identiclone-dx-trg-assay-100583457","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.)",{"count":46,"type":19},250,"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.",[49],"T-Cell Lymphoproliferative Disorder","NOT_YET_RECRUITING","2025-03-10",{"date":53,"type":30},"2025-03-14",{"date":55,"type":19},"2025-06-02",{"date":57,"type":19},"2025-12-06",{"name":36,"class":37},3,""]