[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642296":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Regina Elena Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective Plasma-First NSCLC Cohort",null,"Adult patients with radiological suspicion of locally advanced non-small cell lung cancer (NSCLC) not suitable for locoregional treatment, or metastatic NSCLC, will be enrolled before completion of the standard diagnostic pathway.\n\nParticipants will undergo a peripheral blood draw for liquid biopsy within one week of the first clinical assessment. Plasma-derived circulating nucleic acids will be analyzed using next-generation sequencing (NGS) to evaluate molecular alterations, turnaround time, concordance with tissue-based profiling, and tumor fraction.\n\nAll participants will continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and tissue-based molecular testing. No investigational treatment is assigned, and study procedures will not independently determine treatment decisions.",[13],"Diagnostic Test: Plasma-based liquid biopsy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Plasma-based liquid biopsy","Participants will undergo a peripheral blood draw for plasma-based liquid biopsy within one week of the first clinical assessment. Circulating cell-free nucleic acids extracted from plasma will be analyzed using next-generation sequencing (NGS) to identify molecular alterations and evaluate turnaround time, concordance with tissue-based molecular profiling, and tumor fraction.\n\nThe liquid biopsy is performed for research purposes within this pilot observational study. Participants will continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and standard tissue-based molecular testing. The study procedure will not independently determine treatment decisions.",[9],[21],{"name":22,"affiliation":23,"role":24},"Federico Cappuzzo, MD","IFO-IRE, Istituto Nazionale Tumori Regina Elena","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Maristella Giammaruco, MD","CONTACT","+39 06 5266 5698","maristella.giammaruco@ifo.it",{"name":32,"role":28,"phone":10,"phoneExt":10,"email":10},"Simonetta Buglioni, Biology",[34],{"facility":23,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Roma","RM","00144","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],11.10642,44.99364,{"lat":45,"lon":44},[48,49,52],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},{"name":32,"role":28,"phone":50,"phoneExt":10,"email":51},"+39 06 5266 2923","simonetta.buglioni@ifo.it",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100642296","impact-of-liquid-biopsy-on-the-therapeutic-pathway-for-lung-cancer-advancing-the-molecular-characterization-of-patients-with-advanced-lung-adenocarcinoma-by-integrating-liquid-biopsy-into-the-early-stages-of-the-diagnostic-and-therapeutic-pathway-100642296",false,"NCT07649629","Impact of Liquid Biopsy on the Therapeutic Pathway for Lung Cancer: Advancing the Molecular Characterization of Patients With Advanced Lung Adenocarcinoma by Integrating Liquid Biopsy Into the Early Stages of the Diagnostic and Therapeutic Pathway","Impatto Della Biopsia Liquida Sul Percorso Terapeutico Del Tumore al Polmone: Anticipare la Caratterizzazione Molecolare Dei Pazienti Con Adenocarcinoma Del Polmone in Stadio Avanzato Integrando la Biopsia Liquida Nella Fase Iniziale Del Percorso Diagnostico-terapeutico","INNOVA-LUNG","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Radiological suspicion of locally advanced lung cancer not amenable to locoregional treatment or metastatic lung cancer (stage III-IV).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n* Tissue biopsy and\u002For cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of non-small cell lung cancer (NSCLC).\n* Written informed consent for study participation and personal data processing obtained before any study-specific procedure.\n\nExclusion Criteria:\n\n* Previous or current history of non-small cell lung cancer (NSCLC).\n* Histopathological diagnosis of NSCLC already available following tissue biopsy.\n* Eligibility for surgical removal of tumor tissue.\n* Ongoing or previous systemic oncological treatment for lung cancer.","ALL","18 Years",{"count":66,"type":67},70,"ESTIMATED","OBSERVATIONAL","This multicenter pilot observational study aims to assess the feasibility of introducing liquid biopsy at an early stage of the diagnostic pathway for patients with suspected advanced non-small cell lung cancer (NSCLC).\n\nLiquid biopsy is a minimally invasive blood test that can detect tumor-related genetic alterations in circulating nucleic acids. The study will evaluate whether this approach can provide molecular information more rapidly than standard tissue-based testing and how closely the results obtained from blood samples match those obtained from tumor tissue.\n\nApproximately 70 adult patients with radiological evidence of locally advanced or metastatic lung cancer will be enrolled. Participants will undergo a blood draw for liquid biopsy and will continue to follow the standard diagnostic pathway, including tissue biopsy or cytological sampling when indicated.\n\nThe results generated within the study are intended for research purposes and will not replace standard diagnostic procedures or independently determine treatment decisions. The findings will be used to identify practical and methodological issues and to support the design of future clinical studies on the plasma-first approach.",[71],"Advanced Non-small Cell Lung Cancer (NSCLC)",[73,74,75,76,77,78,79,80,81,82,83,84,85],"Lung Cancer","Liquid biopsy","Plasma-first approach","Non-small cell lung cancer","NSCLC","ctDNA","ctRNA","NGS","Molecular profiling","Tumor fraction","Actionable genomic alterations","Targeted therapy","Biomarkers","2026-06-10",{"date":88,"type":89},"2026-06-16","ACTUAL",{"date":91,"type":89},"2025-09-01",{"date":93,"type":67},"2027-03-01",{"name":5,"class":6},1]