[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553709":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":33,"responsibleParty":49,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":72,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"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,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Beijing","Beijing Municipality","100730","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47],{"name":48,"role":26,"phone":27,"phoneExt":10,"email":28},"Jian Li, MD",{"type":50,"investigatorFullName":25,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Professor","100553709","screening-for-monoclonal-gammopathy-in-individuals-undergoing-physical-examinations-using-ims-lc-assay-technology-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":61,"type":62},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.",[66,67,68],"M Protein","Monoclonal Gammopathy","Monoclonal Gammopathy of Undetermined Significance",[70,71],"M protein","Monoclonal gammopathy of unknown significance","NOT_YET_RECRUITING","2024-07-06",{"date":75,"type":76},"2024-07-09","ACTUAL",{"date":78,"type":62},"2024-07",{"date":80,"type":62},"2025-06",{"name":25,"class":6},1]