[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mgus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mgus":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,68,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100627449","investigating-the-pathogenic-role-of-n-glycosylation-in-al-amyloidosis-molecular-bases-diagnosis-and-treatment-100627449",false,"NCT07448779","Investigating the Pathogenic Role of N-glycosylation in AL Amyloidosis: Molecular Bases, Diagnosis, and Treatment","GlycAL","Inclusion Criteria:\n\n* Diagnosis of monoclonal gammopathy (e.g. AL amyloidosis, MGUS, MM, others)\n* Planned peripheral blood sampling +\u002F- bone marrow aspiration\n* Age \\> 18 years\n* Willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes through signing a written informed consent.\n\nExclusion Criteria:\n\n* Lack of monoclonal gammopathy\n* Patients fulfilling the criteria for complete hematologic response after anti-clonal therapy\n* Age \\\u003C18 years\n* Failure to show willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes.","ALL","18 Years","99 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","Immunoglobulin light chain (AL) amyloidosis is caused by a typically small, minimally proliferating bone marrow plasma cell clone secreting a patient-unique, unstable, aggregation-prone, toxic light chain (LC). The amyloidogenicity of LCs is encrypted in their sequence, yet molecular determinants of LC pathogenicity remain obscure. N-glycosylation has been long suspected to be a determinant of LC amyloidogenicity based on anecdotal reports of individual AL patients with a clonal LC displaying this post-translational modification. It is hypothesized that N-glycosylation fundamentally contributes to determining the amyloidogenicity of immunoglobulin LCs in a subset of patients with AL and might influence its clinical phenotype. It is further proposed that the synthesis and secretion of unstable LCs that also have to be N-glycosylated might reverberate on the biology of the plasma cell clone, possibly modulating the sensitivity toward different drugs and might represent itself a therapeutic target.\n\nThe objective of our study is now to elucidate the molecular role of LC N-glycosylation in AL amyloidosis, exploit it for risk assessment, and define its potential impact on the biology of the underlying plasma cell clone and its drug sensitivity.",[25,26,27,28],"AL Amyloidosis","MGUS","Multiple Myeloma","Monoclonal Gammopathies","RECRUITING","2026-02-25",{"date":32,"type":33},"2026-03-04","ACTUAL",{"date":35,"type":33},"2025-11-17",{"date":37,"type":21},"2027-05-30",{"name":39,"class":40},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100534359","european-myeloma-network-emn-sample-project-100534359","NCT06237803","European Myeloma Network (EMN) Sample Project","EMN Prospective Sample Collection Project","EMN36","Inclusion Criteria:\n\n* Subjects with MGUS, smouldering Multiple Myeloma (SMM) , MM (Multiple Myeloma) (+\u002F- EMD), plasma cell leukemia (PCL) (+\u002F- EMD)\n* Subjects are ≥ 18 years old.\n* Subjects have provided written informed consent in accordance with federal, local, and institutional guidelines prior to initiation of any project-specific activities or procedures.\n\n  1. Subjects do not have kind of condition that, in the opinion of the Investigators, may compromise the ability of the subjects to give written informed consent and\n  2. subjects are, in the investigator's opinion, willing and able to comply with the protocol requirements.\n\nExclusion Criteria:\n\n* Previous treatment with anti-myeloma therapy (excluding one course of therapy in patients in which urgent therapy is deemed necessary according to physician's discretion, e.g. myeloma-related complications resistant to supportive care).\n* Subjects have had prior unforeseen (serious) adverse reactions to blood donation including, but not limited to fainting, angina, severe bruising, allergic reactions, or any other adverse events.\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the protocol and follow-up schedule.",{"count":51,"type":21},6000,"This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples.\n\nThis study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples",[27,54,55,56,26],"Smoldering Multiple Myeloma","Plasma Cell Leukemia","Extramedullary Myeloma","2025-12-02",{"date":59,"type":33},"2025-12-03",{"date":61,"type":33},"2022-12-21",{"date":63,"type":21},"2037-12",{"name":65,"class":66},"European Myeloma Network B.V.","NETWORK",41,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":41},"100480676","a-prospective-long-term-observational-study-in-patients-with-monoclonal-gammopathy-of-undetermined-significance-100480676","NCT05539079","A Prospective Long-term Observational Study in Patients With Monoclonal Gammopathy of Undetermined Significance","SECURE","Inclusion Criteria:\n\n• Any individual with a confirmed or suspected case of MGUS\n\nExclusion Criteria:\n\n* Those who are unable or unwilling to give informed consent\n* Patients under the age of 18\n* Patients with no evidence of MGUS\n* Patients with a light chain ratio of 0.3 to 3.0 without a monoclonal protein on serum electrophoresis or immunofixation\n* Patients with rapidly rising paraprotein or serum free light chains of progressive disease at time of diagnosis or inclusion into study",{"count":76,"type":21},2000,"Multiple Myeloma (MM) is a rare blood cancer affecting over 5000 people a year in the UK. All cases of myeloma start with a condition called monoclonal gammopathy of undetermined significance (MGUS). MGUS occurs in approximately 3.2% of people aged 50 and over. Only a small proportion of these people - around 1% each year - will develop myeloma. Most people with MGUS have no symptoms, but a small number of people will suffer complications. This group are referred to as having monoclonal gammopathy of clinical significance (MGCS).\n\nPeople with myeloma frequently experience long delays in diagnosis; the delays are longer than for any other cancer. Although we know that MGUS leads to myeloma, most cases of MGUS are only found 'incidentally' when the person is having blood tests for something else. And the people who have MGUS do not have consistent testing or follow up. This situation means that 80 - 90% of people who are diagnosed with myeloma did not have an earlier MGUS diagnosis.\n\nEarlier diagnosis of myeloma might be possible with better understanding MGUS and how it should be monitored. The SECURE study will help with this. It will help confirm the rate at which people with MGUS progress to a diagnosis of myeloma. It will further understanding of screening, diagnosis, and monitoring patterns of people with MGUS and MGCS in the UK.\n\nThe study aims to find out more about the role of family history and demographic factors in the development of MGUS. It will also find out more about the psychological impact of an MGUS diagnosis and individual quality of life.\n\nPatients with MGUS will be identified by their clinical care team and invited to participate in the SECURE study. Participants will be required to answer surveys and questionnaires annually for a period of 5 years or until their disease changes. The study will recruit participants from 20 NHS sites in the UK. Some will be asked to provide blood samples. SECURE is funded by Cancer Research UK (CRUK) and the National Institute for Health Research (NIHR).",[26],"2025-07-10",{"date":81,"type":33},"2025-07-15",{"date":83,"type":33},"2023-09-06",{"date":85,"type":21},"2032-12-01",{"name":87,"class":40},"Oxford University Hospitals NHS Trust",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":41},"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.",true,"45 Years",{"count":98,"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.",[27,26,101,102,103],"Gut Microbiota","Infections","M-Protein","2024-09-10",{"date":106,"type":33},"2024-09-19",{"date":108,"type":33},"2024-05-01",{"date":110,"type":21},"2026-12-30",{"name":112,"class":40},"Zhujiang Hospital"]