[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"all-conditions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:all-conditions":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100606250","new-approaches-for-evaluating-the-interchangeability-of-reference-materials-and-quality-controls-comet-mpl-100606250",false,"NCT07173114","New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)","COMET-MPL","Inclusion Criteria:\n\n* Panel 1: adults ≥ 18 years of age.\n* Panel 2: adults ≥ 18 years of age undergoing immunosuppressive treatment (cyclosporine, everolimus, tacrolimus, sirolimus).\n\nExclusion Criteria:\n\n* Protected patients (minors who are not emancipated, individuals who are unable to express their consent, etc.)\n* Individuals who are not affiliated with a social security system\n* Individuals under judicial protection\n* Refusal to give consent to participate in the research","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","1 Day","OBSERVATIONAL","Medical biology tests are essential to clinical decision-making. The European Regulation on in vitro diagnostic medical devices (EU\u002F2017\u002F746) requires metrological traceability of the values assigned to calibrators and quality controls, based on reference measurement methods (RMMs) or certified reference materials (CRMs). However, these references are not available for all analyses, limiting manufacturers' ability to comply with regulatory requirements.\n\nThe dissemination of traceability relies mainly on CRMs. However, to guarantee the validity of the results, these materials must have sufficient commutability, i.e., behavior comparable to that of native biological samples. This property is also required for external quality controls (EQA) used in external quality control programs. Commutability is an essential condition for avoiding matrix effects and ensuring the reliability of results.\n\nThe COMET-MPL project aims to optimize manufacturing processes for commutable, single-parameter, or multi-parameter CRMs and EQA. Evaluate the commutability of these materials in relation to patient samples.\n\nThe COMET-MPL project aims to Produce materials suitable for priority analyses: bilirubin, cyclosporine, parathyroid hormone (PTH), human cytomegalovirus, estradiol.\n\nCommutability will be verified by comparing the performance of CRMs and EQA with that of clinical samples in several French laboratories equipped with automated systems from different manufacturers.",[25,26],"Hospitalization","All Conditions",[28,29,30,31,32],"In Vitro Diagnostics (IVD)","Commutability","Calibration","Interchangeability","Analytical Validity","RECRUITING","2025-09-29",{"date":36,"type":37},"2025-09-30","ACTUAL",{"date":39,"type":37},"2025-09-22",{"date":41,"type":20},"2026-09-22",{"name":43,"class":44},"University Hospital, Montpellier","OTHER",2]