[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"m-protein\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:m-protein":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,64,86,108,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100573798","multi-center-screening-for-serum-m-protein-100573798",false,"NCT06750965","Multi-center Screening for Serum M Protein","Epidemiological Characteristics Associated With Precursor Lesions of Multiple Myeloma Using Serum M Protein Screening: a Multi-center, Prospective Cohort Study.","Inclusion Criteria:\n\n(1) Screening stage\n\n1. Over 30 years old.\n2. Volunteer to participate in this study and sign an informed consent form.\n\n(2) Follow up stage\n\n1. According to previous studies, a positive rate of 5% -8% was found in subjects with positive M protein screening. Each sub center included approximately 50-80 positive subjects based on actual conditions. At the same time, control subjects with negative M protein testing were matched by age and gender parameter 1:1.\n2. Volunteer to participate in the follow-up phase of the study and sign an informed consent form.\n\nExclusion Criteria:\n\n(1) Screening stage\n\n1\\) Previously diagnosed with hematological diseases such as plasma cell or other B lymphocyte proliferative diseases.\n\nCulling criteria:\n\n1. Samples with incomplete or untraceable subject data.\n2. Unqualified samples: including serum samples with severe hemolysis, fatty blood or jaundice, insufficient sample, and samples not stored as required.\n3. The subject requested to withdraw from the study midway.\n4. Duplicate samples of subjects at the same time point.",true,"ALL","30 Years",{"count":20,"type":21},10000,"ESTIMATED","OBSERVATIONAL","This study aims to utilize a highly sensitive method for detecting M protein in serum to examine the prevalence of M protein in various age groups of individuals aged over 30 who underwent physical examinations in different regions of China. Furthermore, the study seeks to analyze the relationship between physical examination indicators and the presence of serum M protein (as measured by relative intensity) in the study participants at the time of enrollment. Additionally, a 5-year follow-up period will be employed to observe the association between annual physical examination indicators and clinical outcomes in subjects identified with positive\u002Fnegative serum M protein screening.",[25,26,27],"Monoclonal Gammopathy","Multiple Myeloma","M-protein",[27],"NOT_YET_RECRUITING","2025-04-07",{"date":32,"type":33},"2025-04-09","ACTUAL",{"date":35,"type":21},"2025-05-01",{"date":37,"type":21},"2029-12-31",{"name":39,"class":40},"Zhujiang Hospital","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":49,"studyType":22,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100492000","screening-and-therapeutic-monitoring-of-multiple-myeloma-by-maldi-tof-ms-analysis-100492000","NCT05686447","Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis","Inclusion Criteria:(1) Inclusion criteria for cases: Serum samples from related people diagnosed with multiple myeloma were included in MALDI-TOF-MS analysis by serum protein electrophoresis (SPEP), serum immunofixation electrophoresis (IFE), Ig isotype detection and other methods. (2) Inclusion criteria of the controls were as follows: individuals in good health without obvious disease and with normal physical examination report; Avoid people who have not suffered from major chronic diseases in recent years, such as hypertension, diabetes, chronic kidney disease, etc; controls were appropriately selected that matched cases for age and sex.\n\n\\-\n\nExclusion Criteria: samples with incomplete sample information and untraceable source; Samples whose sample volume is insufficient for testing; Samples that do not meet the requirements for sample collection and storage\n\n\\-",{"count":48,"type":21},200,"2 Years","To provide a comprehensive MALDI-TOF mass spectrometry method for detecting, characterizing, and quantifying M-protein, and to track M-protein in a very sensitive and specific manner during patient treatment, providing a more precise test for diagnosing disease and monitoring patient response to treatment.",[52,26,27],"Monoclonal Gammopathies",[27],"RECRUITING","2025-04-02",{"date":57,"type":33},"2025-04-06",{"date":59,"type":33},"2023-01-01",{"date":61,"type":21},"2026-07-31",{"name":39,"class":40},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":16,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":63},"100569157","characteristics-and-clinical-significance-of-gut-microbiota-in-patients-with-monoclonal-gammopathy-100569157","NCT06690593","Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy","Gut Microbiota Profiling in Patients With Monoclonal Gammopathy: Implications for Disease Pathogenesis and Progression","(I) Inclusion Criteria:\n\n1. Age 45 years or older;\n2. Negative screening for monoclonal protein by MALDI-TOF MS;\n3. No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study;\n4. Sufficient whole blood, plasma, serum, and stool samples available, and relevant case data can be provided.\n\n(II) Exclusion Criteria:\n\n1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization;\n2. Antibiotic treatment received in the past month; Presence of severe systemic diseases, including malignant tumors;\n3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or other unqualified sample conditions.","45 Years",{"count":73,"type":21},2990,"This is an observational case-control study, aiming to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). The study will collect blood and stool samples from MGUS patients, non-MGUS patients (with similar diseases), and healthy controls, and perform multi-omics detection including microbiomics, peptidomics, and biochemical immunology. It will comprehensively analyze the abnormal features of the gut microbiome in MGUS patients, which may help provide new biomarkers and potential mechanisms for the diagnosis, prognosis evaluation, and treatment strategies of MGUS.",[76,77,26,78],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","Intestinal Flora","M-Protein","2024-12-26",{"date":81,"type":33},"2024-12-27",{"date":79,"type":21},{"date":84,"type":21},"2026-12-30",{"name":39,"class":40},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":16,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":63},"100522412","a-cross-sectional-study-on-the-positive-rate-of-m-protein-based-on-a-highly-sensitive-serum-m-protein-detection-method-100522412","NCT06082284","A Cross-sectional Study on the Positive Rate of M Protein Based on a Highly Sensitive Serum M Protein Detection Method.","A Cross-sectional Study on the Positive Rate of Monoclonal Immunoglobulin (M Protein) in the Serum of Patients Seeking Medical Treatment in Tertiary Hospitals Based on a Highly Sensitive Serum M Protein Detection Method.","Inclusion Criteria:\n\n* Patients attending the outpatient\u002Femergency\u002Finpatient department of Zhujiang Hospital;\n* Age: over 18 years old;\n* There are sufficient remaining serum samples and extensive informed consent has been signed.\n\nExclusion Criteria:\n\n* Early diagnosis of hematological diseases such as plasma cell or other B lymphocyte proliferative diseases；\n* Improper storage or repeated freeze-thaw of remaining serum samples.","18 Years",{"count":20,"type":21},"By using a highly sensitive serum M protein detection method based on the MALDI-TOF MS platform, serum monoclonal immunoglobul (M protein) in detection was performed on the visiting patients to explore the positive rate of serum M protein and its distribution in different departments. And exploring the correlation analysis between the relative concentration of serum M protein based on the above highly sensitive methods and clinical indicators.",[26,97],"M Protein",[99],"M protein","2024-12-17",{"date":102,"type":33},"2024-12-20",{"date":104,"type":33},"2023-10-01",{"date":106,"type":21},"2025-12-31",{"name":39,"class":40},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":16,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":128,"locationsCount":63},"100557570","intestinal-flora-and-immunity-in-monoclonal-gammopathy-patients-100557570","NCT06539832","Intestinal Flora and Immunity in Monoclonal Gammopathy Patients","Correlation Analysis of Intestinal Flora and Immune Function in Patients With Monoclonal Immunoglobulinaemia Co-infection","Inclusion Criteria:\n\n1. Age 45 years and older; and\n2. Patients who were monoclonal gammaglobulin negative by MALDI-TOF MS screening;\n3. No symptoms of infection and normal indicators of infection (whole blood hs-CRP, serum IL-6, PCT);\n4. Sufficient remaining whole blood, plasma and faecal samples are available, and relevant case information can be provided.\n\nExclusion Criteria:\n\n1. Those with a previous history of intestinal tumour, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital; and\n2. Patients receiving antibiotic therapy in the last month\n3. Severe systemic diseases including malignant tumours;\n4. Insufficient remaining sample volume, or the presence of sample failure such as severe haemolysis, lipaemia or jaundice.",{"count":116,"type":21},300,"This study aims to investigate the characteristics of the gut microbiota and immune function status in patients with monoclonal gammopathy complicated by infection, and to analyze the correlation between the two.200 patients diagnosed with monoclonal gammopathy by MALDI-TOF MS were included, of which 100 had concurrent infections and 100 did not. An additional 100 healthy controls, matched for age and gender, were also enrolled.By comparing the composition of the gut microbiota and immune function markers (such as peripheral blood immune cell profiles and cytokine levels) between the patient groups and the control group, the study will evaluate the dysbiosis of the gut microbiota and abnormal immune status in patients with monoclonal gammopathy complicated by infection. The aim is to explore the correlation between the gut microbiome alterations and immune dysfunction, in order to provide a basis for further investigation of the underlying mechanisms.",[26,119,120,121,78],"MGUS","Gut Microbiota","Infections","2024-09-10",{"date":124,"type":33},"2024-09-19",{"date":126,"type":33},"2024-05-01",{"date":84,"type":21},{"name":39,"class":40},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":63},"100553709","screening-for-monoclonal-gammopathy-in-individuals-undergoing-physical-examinations-using-ims-lc-assay-technology-100553709","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",{"count":136,"type":21},15600,"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.",[97,25,139],"Monoclonal Gammopathy of Undetermined Significance",[99,141],"Monoclonal gammopathy of unknown significance","2024-07-06",{"date":144,"type":33},"2024-07-09",{"date":146,"type":21},"2024-07",{"date":148,"type":21},"2025-06",{"name":150,"class":40},"Jian Li"]