[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553709":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":33,"responsibleParty":48,"collaborators":10,"id":51,"slug":10,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":10,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Clinical patients",null,"Residual plasma specimens for iMS-LC Assay to detect M protein",[13],"Diagnostic Test: M protein detection by iMS-LC Assay",{"label":15,"type":10,"description":11,"interventionNames":16},"Individuals undergoing routine physical examinations",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DIAGNOSTIC_TEST","M protein detection by iMS-LC Assay","iMS-LC Assay (intact M-protein Screening-Light Chain Assay) technology is a new method for the specific identification of M-proteins in peripheral blood, based on mass spectrometry recognition of intact clonal immunoglobulin light chains. Combined with AI algorithm models, M-proteins can be easily distinguished from the polyclonal background, enabling automated identification and quantitative analysis of M-proteins.\n\nPrevious studies have shown that the detection limit of the iMS-LC Assay is several times higher than that of IFE. Additionally, the iMS-LC Assay requires only 5 μL of peripheral blood serum for detection, offering advantages over traditional methods in terms of higher sensitivity, non-invasiveness, lower sample volume requirements, reduced detection costs, and higher throughput.",[9,15],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Jian Li","CONTACT","+86-18610852525","lijian@pumch.cn",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Zihan Yang","+86-18800173196","yzh18800173196@163.com",[34],{"facility":5,"status":10,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Beijing","Beijing Municipality","100730","China",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46],{"name":47,"role":26,"phone":27,"phoneExt":10,"email":28},"Jian Li, MD",{"type":49,"investigatorFullName":25,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Professor","100553709",false,"NCT06489613","Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology.","Inclusion Criteria:\n\n1. Clinical patients:\n\n   * ≥18 years old;\n   * have concurrent SPEP + SIFE + FLC test results.\n2. Individuals undergoing routine physical examinations:\n\n   * ≥30 years old;\n   * have concurrent SPEP test results.\n\nExclusion Criteria:\n\n* NA","ALL","18 Years",{"count":59,"type":60},15600,"ESTIMATED","OBSERVATIONAL","iMS-LC Assay (intact M-protein Screening-Light Chain Assay) is a new technology based on mass spectrometry identification of intact clonal immunoglobulin light chains for the specific detection of M-proteins in peripheral blood.\n\nThe investigators propose to conduct a prospective, single-center observational study to screen for M-proteins in the peripheral blood of individuals undergoing routine physical examinations using iMS-LC Assay technology. The goals of this observational study are : (1) to evaluate the diagnostic efficacy of detecting peripheral blood M-proteins using the iMS-LC Assay method; and (2) to determine the prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.\n\nInitially, the investigators will collect clinical patient samples continuously and conduct a diagnostic trial of the iMS-LC Assay, using the clinical methods SPEP + SIFE + FLC as the gold standard. Based on the diagnostic performance of the iMS-LC Assay, the investigators will then screen for M-proteins in continuous samples from individuals undergoing routine physical examinations, to further determine the prevalence of MGUS in this population based on mass spectrometry screening.",[64,65,66],"M Protein","Monoclonal Gammopathy","Monoclonal Gammopathy of Undetermined Significance",[68,69],"M protein","Monoclonal gammopathy of unknown significance","NOT_YET_RECRUITING","2024-07-06",{"date":73,"type":74},"2024-07-09","ACTUAL",{"date":76,"type":60},"2024-07",{"date":78,"type":60},"2025-06",{"name":25,"class":6},1]