[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495018":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":12,"responsibleParty":35,"collaborators":38,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":7,"enrollmentInfo":52,"targetDuration":7,"studyType":55,"phases":7,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":15,"whyStopped":7,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"University of Bologna","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Gut microbiome analysis","Characterization of the compositional and functional modifications of gut microbiome in patients affected by lymphoma undergoing therapy with CAR-T cells from baseline until the restaging after 18 months from the CAR-T cell infusion",[13],{"facility":14,"status":15,"city":16,"state":7,"zip":17,"country":18,"countryCode":19,"cosmosGeoPoint":20,"geoPoint":25,"contacts":26},"Institute Of Hematology \"Seràgnoli\"","RECRUITING","Bologna","40138","Italy","IT",{"type":21,"coordinates":22},"Point",[23,24],11.33875,44.49381,{"lat":24,"lon":23},[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Pier Luigi Zinzani, MD","CONTACT","+39 051 636","4042","pierluigi.zinzani@unibo.it",{"name":28,"role":34,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"type":34,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Pier Luigi Zinzani","Full Professor of Hematology",[39,41],{"name":40,"class":6},"Associazione Italiana per la Ricerca sul Cancro",{"name":42,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","100495018","role-of-the-gut-microbiome-in-the-outcome-of-diffuse-large-b-cell-lymphoma-patients-treated-with-car-t-cell-therapy-100495018",false,"NCT05725720","Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy","MicroCar","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Patients affected by histologically confirmed DLBCL.\n3. Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products).\n4. Patients must provide written informed consent.\n\nExclusion Criteria:\n\n1. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.\n2. Concurrent second malignancy.","ALL","18 Years",{"count":53,"type":54},90,"ESTIMATED","OBSERVATIONAL","Despite impressive outcomes in selected patients, significant heterogeneity in clinical response to CAR-T cell therapy remains. The gut microbiome (GM) has recently emerged as one of the key modifiable factors of prognosis and response to treatment in cancer patients, with high-diversity profiles rich in health-associated taxa while poor in pathobionts generally associated with better response and longer survival. Currently, it is unknown if GM also modulates anti-tumor responses to CAR-T cells and related toxicities in lymphomas.",[58],"Diffuse Large B Cell Lymphoma",[60,61],"Gut microbiome","CAR T-cell therapy","2023-06-15",{"date":64,"type":65},"2023-06-18","ACTUAL",{"date":67,"type":65},"2023-03-23",{"date":69,"type":54},"2027-12",{"name":5,"class":6},1]