[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385545":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":98,"collaborators":10,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":10,"enrollmentInfo":109,"targetDuration":10,"studyType":112,"phases":10,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective cohort",null,"Prospective cohort: All patients with diagnosis of DLBCL afferring referred to IRST-IRCCS, Oncology-Hematology Units of AVR, S. Orsola Hospital (Bologna).",[13],"Other: Prospective cohort",{"label":15,"type":10,"description":16,"interventionNames":17},"Retrospective cohort","Retrospective cohort: Patients with diagnosis of DLBCL referred to IRST-IRCCS, from 2011 to 2017 for whom clinical data and FFPE samples are available.",[18],"Other: Retrospective cohort",[20,23],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":10},"Immunohistochemical determinations: Cell of Origin (COO) (according with Hans algorithm), evaluation of Cluster of Differentiation (CD) (CD20, CD5, CD10), Bcl6, Bcl2 (cut off\\>50%), MUM1\u002FIRF4, c-myc (cut off\\>40%) and Ki67, FISH for c-myc and if rearranged for Bcl2 e Bcl6.\n\nmRNA expression by Nanostring Single cell analysis Immune checkpoint expression Proteomic analysis Metabolic analysis Radiomic analysis",[9],{"type":6,"name":15,"description":21,"armGroupLabels":24,"otherNames":10},[15],[26],{"name":27,"affiliation":28,"role":29},"Gerardo Musuraca, MD","IRST IRCCS","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Oriana Nanni, Dr","CONTACT","+39 0543739100","oriana.nanni@irst.emr.it",{"name":37,"role":33,"phone":38,"phoneExt":10,"email":39},"Bernadette Vertogen, Dr","+39 0544285813","cc.ubsc@irst.emr.it",[41,58,73,85],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Irst Irccs","RECRUITING","Meldola","FC","47014","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],12.0626,44.12775,{"lat":53,"lon":52},[56],{"name":27,"role":33,"phone":34,"phoneExt":10,"email":57},"gerardo.musuraca@irst.emr.it",{"facility":59,"status":43,"city":60,"state":61,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Ospedale S. Maria delle Croci RAVENNA","Ravenna","RA","48121",{"type":50,"coordinates":64},[65,66],12.20121,44.41344,{"lat":66,"lon":65},[69],{"name":70,"role":33,"phone":71,"phoneExt":10,"email":72},"Monica Tani, MD","054428","monica.tani@ausl.romagna.it",{"facility":74,"status":43,"city":75,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"L'Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola-Malpighi","Bologna",{"type":50,"coordinates":77},[78,79],11.33875,44.49381,{"lat":79,"lon":78},[82],{"name":83,"role":33,"phone":10,"phoneExt":10,"email":84},"Elena Sabbatini, MD","elena.sabattini@aosp.bo.it",{"facility":86,"status":43,"city":87,"state":10,"zip":88,"country":47,"countryCode":48,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Ospedale Infermi","Rimini","47924",{"type":50,"coordinates":90},[91,92],12.56528,44.05755,{"lat":92,"lon":91},[95],{"name":96,"role":33,"phone":10,"phoneExt":10,"email":97},"Annalia Molinari, MD","annalia.molinari@auslromagna.it",{"type":99,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100385545","mixed-molecular-clinical-index-mmci-in-diffuse-large-b-cell-lymphoma-dlbcl-100385545",false,"NCT04300101","Mixed Molecular Clinical Index (MMCI) in Diffuse Large B-cell Lymphoma (DLBCL)","MMCI","Inclusion Criteria for the prospective cohort:\n\n* New diagnosis of High grade Diffuse large B cell Lymphoma undergoing first line standard treatment;\n* Signed written informed consent;\n* Availability of FFPE sample.\n\nInclusion Criteria for the retrospective cohort:\n\n* Diagnosis of High grade Diffuse large B cell Lymphoma from 2011 to 2017;\n* Availability of FFPE sample and clinical data.\n\nExclusion Criteria:\n\n* Patients included in clinical trials.","ALL","18 Years",{"count":110,"type":111},300,"ESTIMATED","OBSERVATIONAL","This is a prospective and retrospective observational study. The primary objective is to identify new prognostic biomarkers for DLBCL patients in terms of progression-free survival (PFS) and able to add predictive capacity to recognized important clinical factors.\n\nThe secondary objectives are:\n\n* to identify new biomarkers associated with overall survival (OS) and objective response rate (ORR)\n* to characterize tissue and circulating immune microenvironment of DLBCL patients by bulk and single cell transcriptomics;\n* to assess the correlation between the expression of immune checkpoint genes and mRNA signature;\n* to describe the mutational status of a panel of genes relevant to DLBCL pathogenesis;.\n* to assess the correlation between protein expression, mutational status and the messenger RNA (mRNA) signature.\n* to investigate the association between radiomic features obtained from PET images and patient and tumour characteristics and clinical outcomes (PFS, OS, ORR).\n\nFor each enrolled patient, immunohistochemical determinations will be performed: Cell of origin (COO) (Germinal Cell -GC- or activated B-cell - ABC- type according with Hans algorithm ), evaluation of cluster of differentiation antigen 20 (CD20), cluster of differentiation antigen 5 (CD5), cluster of differentiation antigen 10 (CD10), Bcl6, Bcl2 (cut off\\>50%), Multiple Myeloma 1 \u002F Interferon Regulatory Factor 4 protein (MUM1\u002FIRF4), c-myc (cut off\\>40%) and Ki67, fluorescence in situ hybridization (FISH) for c-myc and if rearranged, for Bcl2 e Bcl6 ). Moreover, paraffin embedded (FFPE) tumor specimens will be collected for RNA extraction and mRNA expression mutational and proteomics analysis, centralized at IRST-IRCCS.",[115],"Diffuse Large B Cell Lymphoma",[117,118,119,120],"Diffuse Large B cell lymphoma;","cell of origin","gene expression","immunohistochemistry","2025-04-07",{"date":123,"type":124},"2025-04-10","ACTUAL",{"date":126,"type":124},"2020-05-14",{"date":128,"type":111},"2028-05",{"name":5,"class":6},4]