[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561051":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":26,"responsibleParty":51,"collaborators":7,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":7,"enrollmentInfo":63,"targetDuration":7,"studyType":66,"phases":7,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Flow Cytometry","Study of t cell population in flow cytometry",[14],{"name":15,"affiliation":5,"role":16},"Stefan Hohaus, MD","PRINCIPAL_INVESTIGATOR",[18,23],{"name":15,"role":19,"phone":20,"phoneExt":21,"email":22},"CONTACT","063015","4180","stefan.hohaus@unicatt.it",{"name":24,"role":19,"phone":20,"phoneExt":21,"email":25},"Flaminia Bellisario, MD","flaminia.bellisario@guest.policlinicogemell.it",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Stefan Hohaus","RECRUITING","Rome","Lazio","00168","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],12.51133,41.89193,{"lat":39,"lon":38},[42,43,45,48,49],{"name":15,"role":19,"phone":20,"phoneExt":21,"email":22},{"name":24,"role":19,"phone":20,"phoneExt":21,"email":44},"flaminia.bellisario@guest.policlinicogemelli.it",{"name":46,"role":47,"phone":7,"phoneExt":7,"email":7},"Silvia Bellesi, MD","SUB_INVESTIGATOR",{"name":24,"role":47,"phone":7,"phoneExt":7,"email":7},{"name":50,"role":47,"phone":7,"phoneExt":7,"email":7},"Francesco D'Alò, MD",{"type":52,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100561051","flow-cytometry-for-the-study-of-t-cell-populations-in-hemophagocytic-lymphohistiocytosis-associated-with-lymphomas-100561051",false,"NCT06585124","Flow Cytometry for the Study of T-Cell Populations in Hemophagocytic Lymphohistiocytosis Associated With Lymphomas","Observational Study on the Application of Flow Cytometry for the Study of T-Cell Populations in Lymphoma-associated Hemophagocytic Lymphohistiocytosis","LA-HLH","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Diagnosis at onset of aggressive lymphoma including the following histotypes:\n\n   * Hodgkin lymphoma\n   * Transformed B cell lymphomas;\n   * Diffuse large B-cell lymphomas (diffuse large B-cell lymphoma NOS; T-cell\u002Fhistiocyte-rich B-cell lymphoma; High grade B-cell lymphoma\u002Fhigh grade B-cell lymphoma with MYC and BCL2 rearrangement ALK-positive large B-cell lymphoma; Large B-cell lymphoma with IRF4 rearrangement; High grade B-cell lymphoma with 11q alterations; Lymphomatoid granulomatosis; EBV-positive large B-cell lymphoma Large B-cell lymphoma associated with chronic inflammation; Fibrin-associated large B-cell lymphoma; Fluid overload-associated large B-cell lymphoma; Plasmoblastic lymphoma; Immune-privileged site B-cell lymphoma Primary cutaneous leg-type large B-cell lymphoma; Intravascular large B-cell lymphoma; Primary mediastinal large B-cell lymphoma; Mediastinal grey zone lymphoma; High grade NOS B-cell lymphoma)\n   * Burkitt lymphoma\n   * KSHV\u002FHHV8 a ssociatedlymphomas\n   * Lymphomas associated with immunodeficiency or immune dysregulation\n   * Mature T-cell-derived lymphomas (NOS peripheral T-cell lymphoma; Nodal follicular helper T-cell lymphoma; Anaplastic large cell lymphoma; Nodal and extranodal EBV-positive T\u002FNK-cell lymphomas; Hepatosplenic T-cell lymphoma; Enteropathy-associated intestinal T-cell lymphoma, epitheliotropic monomorphic and NOS; Subcutaneous T-cell lymphoma similar to panniculitis)\n3. Informed consent to the use of biologic materials for studies related to the present proposal.\n\nExclusion Criteria:\n\n1. Diagnosis of indolent non-Hodgkin's lymphoma or diagnoses other than those listed in the inclusion criteria\n2. Prolonged steroid therapy, defined as lasting more than 15 days or high doses of steroid, exceeding 1 mg\u002Fkg\n3. Age ≤ 18 years;","ALL","18 Years",{"count":64,"type":65},150,"ESTIMATED","OBSERVATIONAL","The goal of this study is to explore the associations between T cell activation and the occurrence of hemophagocytic lymphohistiocytosis (HLH) in patients with newly diagnosed lymphomas. The specific aims are:\n\nPrediction of Lymphoma-Associated HLH (LA-HLH): Compare flow cytometric T cell activation markers with the H-score to predict LA-HLH.\n\nIdentification of new markers for predicting HLH in patients with aggressive lymphoma.\n\nDescription of the incidence rate of LA-HLH. Assessment of the outcomes of LA-HLH identified by flow cytometric analysis or the H-score.\n\nThis prospective, single-center observational study will include 150 patients newly diagnosed with aggressive lymphoma within one year. Peripheral blood samples will be taken at diagnosis alongside routine blood chemistry tests for flow cytometric analysis of the T-lymphocyte activation profile. Data on disease characteristics will be collected to calculate the H-score, HLH-2004 score, and OHI score for diagnosing HLH. The flow cytometry results will be compared with these scores to evaluate their effectiveness in diagnosing LA-HLH.",[69,70],"Lymphoma","Hemophagocytic Lymphohistiocytoses",[11,72,73,74],"T cell activation","lymphoma","HLH","2024-09-03",{"date":77,"type":78},"2024-09-05","ACTUAL",{"date":80,"type":78},"2024-05-01",{"date":82,"type":65},"2026-05-01",{"name":5,"class":6},1]