[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431481":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":19,"centralContacts":39,"locations":45,"responsibleParty":73,"collaborators":75,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":19,"enrollmentInfo":96,"targetDuration":19,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":48,"whyStopped":19,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Centre Hospitalier Universitaire, Amiens","OTHER",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with confirmed HVS","EXPERIMENTAL","presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g\u002FL (densitometry) or cryoglobulin activity",[13,14,15],"Other: fundoscopic picture","Biological: blood sample","Procedure: bone marrow sample",{"label":17,"type":18,"description":19,"interventionNames":20},"Patients with confirmed absence of HVS","ACTIVE_COMPARATOR",null,[13,14,15],{"label":22,"type":10,"description":19,"interventionNames":23},"Remaining patients",[13,14,15],[25,29,34],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":19},"fundoscopic picture","A central review of numerised fundoscopic picture will be performed.",[9,17,22],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":19},"BIOLOGICAL","blood sample","Two 10 ml blood vials will be sampled in addition to standard blood sampling for getting 6 to 7 200 μL aliquot.\n\nOne 5 ml EDTA vial for GP1bα expression study, only if this sample can be sent to hemostasis laboratory within the 4 hours after sampling",[9,17,22],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":19},"PROCEDURE","bone marrow sample","Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM",[9,17,22],[40],{"name":41,"role":42,"phone":43,"phoneExt":19,"email":44},"Magalie JORIS, MD","CONTACT","03 22 45 54 19","joris.magalie@chu-amiens.fr",[46],{"facility":47,"status":48,"city":49,"state":19,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"CHU Amiens","RECRUITING","Amiens","80480","France","FR",{"type":54,"coordinates":55},"Point",[56,57],2.3,49.9,{"lat":57,"lon":56},[60,62,65,67,69,71],{"name":41,"role":42,"phone":61,"phoneExt":19,"email":44},"03.22.45.54.19",{"name":63,"role":64,"phone":19,"phoneExt":19,"email":19},"Fabrice JARDIN, MD","PRINCIPAL_INVESTIGATOR",{"name":66,"role":64,"phone":19,"phoneExt":19,"email":19},"Xavier TROUSSARD, MD",{"name":68,"role":64,"phone":19,"phoneExt":19,"email":19},"Gandhi DAMAJ, MD",{"name":70,"role":64,"phone":19,"phoneExt":19,"email":19},"Stéphanie POULAIN, MD",{"name":72,"role":64,"phone":19,"phoneExt":19,"email":19},"Daniela ROBU, MD",{"type":74,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[76,79,81,83,85],{"name":77,"class":78},"Centre Hospitalier Saint Vincent","UNKNOWN",{"name":80,"class":6},"Centre Henri Becquerel",{"name":82,"class":6},"University Hospital, Caen",{"name":84,"class":6},"University Hospital, Lille",{"name":86,"class":6},"Centre Hospitalier de Lens","100431481","clinical-study-of-the-hyperviscosity-syndrome-in-waldenstrm-macroglobulinemia-100431481",false,"NCT04898647","Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia","SLPRaresHvisc","Inclusion Criteria:\n\n* Patient with WM\n* Patients that may require a first-line or subsequent-line therapy\n* patients who will require treatment initiation\n* patients with serum monoclonal component concentration greater than 15 g\u002FL and who will underwent hyperviscosity assessment, even if hyperviscosity is not found and in the absence of other treatment criteria, no treatment is finally initiated.\n* Patients agreeing to give informed consent.\n\nExclusion Criteria:\n\n* Patients with another chronic B-cell malignancy\n* patients with lymphoplasmacytic proliferations\n* patients with marginal zone lymphoma.\n* patients with WM and histologic transformation\n* Absence of informed consent.","ALL","18 Years",{"count":97,"type":98},100,"ESTIMATED","INTERVENTIONAL",[101],"NA","Walsdenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. Clinical manifestations of the hyperviscosity syndrome (HVS) are related to the large amount of IgM in circulating blood or to some physicochemical characteristics such as the presence of a cryoglobulin property. Although HVS is one of the most frequent criteria for initiating therapy in WM, few studies focused on its description and no diagnostic criteria are available.\n\nThe present study aims to identify a diagnostic system for HVS, taking into account objective symptoms such as bleedings, fundoscopic findings and also subjective symptoms such as fatigue and comorbidities that may influence the severity of symptoms.",[104,105],"Hyperviscosity Syndrome","Waldenstrom Macroglobulinemia",[104,105],"2025-05-23",{"date":109,"type":110},"2025-05-29","ACTUAL",{"date":112,"type":110},"2021-05-14",{"date":114,"type":98},"2026-08",{"name":5,"class":6},1]