[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495018":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":22,"armGroups":18,"interventions":23,"overallOfficials":18,"centralContacts":18,"locations":27,"responsibleParty":50,"collaborators":53,"id":58,"slug":18,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":18,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":18,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":30,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Bologna","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Characterization of GM heterogeneity (taxa) in diffuse large B-cell lymphoma patients undergoing CAR-T cell therapy.","Characterization of the compositional and functional modifications of GM 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. GM profiling will be achieved by next-generation sequencing approaches, including 16S rRNA gene-based sequencing for diversity and compositional structure, and shotgun metagenomics for species-level and functional insights, including information on eukaryotes and viruses.","24 months",[14],{"measure":15,"description":16,"timeFrame":17},"Correlation between GM and CAR-T cell therapy outcomes in terms of response, toxicity and disease control.","Define novel GM signatures that relate to more favorable response to the CAR-T treatment and\u002For reducing the occurrence of side effects.","4 years",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","PROSPECTIVE","Up to 90 relapsed\u002Frefractory diffuse large B-cell lymphoma adult (≥18 years) patients undergoing CAR-T cell therapy will be enrolled over 3 years, treated and followed up with fecal sample collection until 18 months after CAR-T cell infusion.",[24],{"type":6,"name":25,"description":26,"armGroupLabels":18,"otherNames":18},"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",[28],{"facility":29,"status":30,"city":31,"state":18,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Institute Of Hematology \"Seràgnoli\"","RECRUITING","Bologna","40138","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],11.33875,44.49381,{"lat":39,"lon":38},[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Pier Luigi Zinzani, MD","CONTACT","+39 051 636","4042","pierluigi.zinzani@unibo.it",{"name":43,"role":49,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Pier Luigi Zinzani","Full Professor of Hematology",[54,56],{"name":55,"class":6},"Associazione Italiana per la Ricerca sul Cancro",{"name":57,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","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":67,"type":68},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.",[72],"Diffuse Large B Cell Lymphoma",[74,75],"Gut microbiome","CAR T-cell therapy","2023-06-15",{"date":78,"type":79},"2023-06-18","ACTUAL",{"date":81,"type":79},"2023-03-23",{"date":83,"type":68},"2027-12",{"name":5,"class":6},1]