[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578131":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":22,"responsibleParty":38,"collaborators":10,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":10,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":10,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},{"fullName":5,"class":6},"Regina Elena Cancer Institute","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Retrospective court of identification",null,"The retrospective identification cohort consists of patients with metastatic disease treated with front line immunotherapy as per clinical practice from 2017 to 2021 at the IRCCS National Cancer Institute \"Regina Elena\".\n\nThe optimal parameters for identifying KEAPness and obtaining information on the interactions between pairs of genes fundamental for the activation of KEAPness itself.",{"label":13,"type":10,"description":14,"interventionNames":10},"Prospective validation cohort","The validation court will collect NSCLC patients (metastatic setting, treated with first-line immunotherapy possibly in association with chemotherapy as per clinical practice) and also pancancer patients (patients with metastatic cancer other than NSCLC and who have received an ICI, either alone or in association with other medical treatments as per clinical practice), from which patients with NSCLC are excluded (PCC cohort). These patients will be recruited from the collaborating institute IRCCS Pascale of Naples. To ensure reproducibility of the study, the same approach of the first court will be applied to this one, i.e. the optimal parameters will be set for the identification of KEAPness and to obtain information on the interactions between pairs of genes fundamental for the activation of KEAPness.",[16],{"name":17,"role":18,"phone":19,"phoneExt":20,"email":21},"Marcello Maugeri Saccà, Medical Doctor","CONTACT","+39 06 5266 6914","+39","marcello.maugerisacca@ifo.it",[23],{"facility":24,"status":25,"city":26,"state":10,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"IRCCS National Cancer Institute \"Regina Elena\"","RECRUITING","Rome","00144","Italy","IT",{"type":31,"coordinates":32},"Point",[33,34],12.51133,41.89193,{"lat":34,"lon":33},[37],{"name":17,"role":18,"phone":19,"phoneExt":20,"email":21},{"type":39,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100578131","transcriptional-framework-for-the-molecular-diagnosis-of-response-to-immunotherapy-in-lung-cancer-with-agnostic-potential-100578131",false,"NCT06807307","Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential","KEAPnes: Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential","KEAPnes","Inclusion Criteria cohort (NSCLC-IC):\n\n* Age \\>18 years;\n* Histological diagnosis of NSCLC\n* metastatic disease\n* Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (surgical or by biopsy) before administration of any anti-tumor treatment (chemotherapy and\u002For radiotherapy);\n* ECOG PS 0-2;\n* Adequate hematological, hepatic and renal function;\n* Measurable disease according to RECIST criteria\n* Availability of follow-up data for at least 6 months and\u002For until death\u002Fprogression\n\nExclusion Criteria cohort (NSCLC-IC):\n\n* Previous systemic therapy for metastatic disease;\n* Comorbidities not controlled with adequate medical therapy.\n\nInclusion Criteria NSCLC-VC cohort:\n\n* Age \\>18 years;\n* Histological diagnosis of NSCLC\n* metastatic disease\n* Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (during surgery and\u002For by biopsy) before administration of any anti-tumor treatment (chemotherapy and\u002For radiotherapy);\n* ECOG PS 0-2;\n* Adequate hematological, hepatic and renal function;\n* Measurable disease according to RECIST criteria;\n* Written informed consent (participation in the study and data processing)\n\nExclusion Criteria NSCLC-VC cohort:\n\n* Previous systemic treatment for metastatic disease;\n* Comorbidities not controlled with adequate medical therapy;","ALL","18 Years",{"count":51,"type":52},256,"ESTIMATED","OBSERVATIONAL","Through genomic and transcriptomic sequencing techniques (whole exome sequencing, WES; whole transcriptome sequencing, WTS) patients with enrichment for KEAPness and specific gene interactions associated with it.",[56],"NSCLC","2025-01-29",{"date":59,"type":60},"2025-02-04","ACTUAL",{"date":62,"type":60},"2024-06-04",{"date":64,"type":52},"2026-06-04",{"name":5,"class":6},1]