[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"waldenstroms-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:waldenstroms-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100509313","prognostic-analyses-on-a-validation-series-of-patients-with-waldenstrms-disease-100509313",false,"NCT05911802","Prognostic Analyses on a Validation Series of Patients With Waldenström's Disease","Prognostic Analyses on a Validation Series of Patients With Waldenström's Disease: Validation of International Prognostic Indexes, Evaluation of Progression-free Survival as a Surrogate Endpoint for Overall Survival. A FILO Study.","SérieProWM","Inclusion Criteria:\n\n* Patient with WM, fulfilling the diagnostic criteria defined at the 2nd Workshop on WM.\n* Patient in whom follow-up is available until at least 01\u002F01\u002F2020. Each participating center should not enroll more 10% of patients lost to follow-up.\n* Patient for whom a minimum annual follow-up is planned until 2024.\n* Having given their consent for this study\n\nExclusion Criteria:\n\n* Patient with other chronic lymphoid malignancy. Special attention will be paid to exclude other lymphoplasmacytic proliferations, especially marginal zone lymphoma.\n* Patient with histological transformation in a diffuse large B-cell lymphoma or any other lymphoma at the time of the initiation of the 1st treatment.\n* No consent for this study.","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","5 Years","OBSERVATIONAL","Waldenström's macroglobulinemia (WM) is defined by the association of bone marrow lymphoplasmocytic infiltration and monoclonal immunoglobulin M (IgM). A mutation in the MYD88 gene is found in up to 90% of patients, and a mutation in the CXCR4 gene in approximately one third of patients. Treatment should be initiated in cases of cytopenia, bulky disease or when the physicochemical or immunological properties of IgM explain the occurrence of amyloidosis, cryoglobulin, neurological manifestations, or hyperviscosity syndrome (due to the presence of a large amount of IgM). However, approximately 30% of patients are diagnosed without any symptom and therefore they do not meet the criteria for initiating treatment.\n\nAt the time of initiation of the first treatment, the prognosis is usually estimated with the International Prognostic Index (IPSSWM) which is based on five variables: age, platelet count, haemoglobin concentrations, β2-microglobulin and monoclonal component concentration. Serum albumin and lactate dehydrogénase (LDH) levels also retain a prognostic role and these two characteristics have been incorporated in a proposal for a revision of this index.\n\nImproving prognostic assessment at the time of the first treatment initiation and taking into account the prognostic impact of events occurring in the course of evolution, should improve the strength of treatment decision at the time of initial treatment and during the follow-up. It should also help to design clinical trial for fast and effective evaluation of new treatments. Our work should also help to adjust clinical monitoring of asymptomatic patients.\n\nProspective and retrospective multicenter prognostic study with a descriptive objective, associated with a biological collection appropriately annotated and stored. A retrospective series including 470 patients with symptomatic WM is already available. The follow-up of these patients will be updated and an additional series of 250 symptomatic patients will be prospectively enrolled. 250 asymptomatic patients will be also enrolled.",[26,27],"Waldenstrom's Disease","Prognostic Index","RECRUITING","2025-11-21",{"date":31,"type":32},"2025-11-26","ACTUAL",{"date":34,"type":32},"2023-08-11",{"date":36,"type":21},"2030-06-15",{"name":38,"class":39},"French Innovative Leukemia Organisation","OTHER",15,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100431090","prognostic-value-of-circulating-tumoral-dna-after-the-first-6-months-of-treatment-in-patients-with-waldenstrm-macroglobulinemia-100431090","NCT04893564","Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia","SLP-rares","Inclusion Criteria:\n\n* Patient with WM according to diagnostic criteria\n* Patients with WM followed in one of the centre of North-Western region.\n* Patients requiring first-line or subsequent-line therapy\n* Patients agreement for giving informed consent.\n* Social insurance system affiliation\n\nExclusion Criteria:\n\n* Patients with another chronic B-cell malignancy\n* patients with other lymphoplasmacytic proliferations\n* patients with marginal zone lymphoma.\n* Patients with WM and histologic transformation\n* Absence of informed consent",{"count":49,"type":21},90,"INTERVENTIONAL",[52],"NA","Waldenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. This chronic lymphoproliferative disorder requires treatment only in case of symptoms, according to accurate criteria described during the second Workshop on WM i.e. in case of cytopenia, bulky organomegaly, immunological or physicochemical consequences of the presence of IgM in circulating blood. A MYD88 mutation, typically a MYD88(L265P), is found in 90% of WM patients. Other gene abnormalities have been observed, the most frequent is a mutation in the CXCR4 gene. Overall, gene mutations in WM involve only a limited number of signalling pathways, yielding the activation of NFkB, namely : the TLR and MYD88 pathway (with an activation of NFkB and BTK in case of MYD88(L265P) mutation), the BCR pathway (involving btk and associated with activations of both NFkB, and erk akt pathway) and the CXCR4 pathway (CXCR4 is a receptor of CXCL12, it is also associated with activations of ERK\u002FMAPK and PI3K). Abnormalities of some of genes, such as TP53, of the expression of the protein CXCL13 and genes involved in the interleukin 6 secretion have been associated with some clinical characteristics.\n\nThe purpose of this project is to define the prognostic role of the detection of circulating tumoral DNA (ctDNA) at the end of treatment for the progression\u002Frelapse risk within the first 3 years after the first 6 months of treatment.",[26,55],"Waldenstrom Macroglobulinemia",[26,55],"2025-09-02",{"date":59,"type":32},"2025-09-09",{"date":61,"type":32},"2022-05-16",{"date":63,"type":21},"2028-07",{"name":65,"class":39},"Centre Hospitalier Universitaire, Amiens",1]