[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495809":3},{"organization":4,"outcomesModule":7,"designInfo":85,"detailedDescription":88,"studyPopulation":89,"armGroups":90,"interventions":104,"overallOfficials":109,"centralContacts":114,"locations":123,"responsibleParty":143,"collaborators":64,"id":145,"slug":64,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":153,"minAge":154,"maxAge":64,"enrollmentInfo":155,"targetDuration":64,"studyType":158,"phases":64,"briefSummary":159,"conditions":160,"keywords":64,"overallStatus":126,"whyStopped":64,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"OncoHost Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":64,"otherOutcomes":65},[9,13,15,17,19,21,23,25,27,31,33,35,37,39,41,43,45,47,49,52,53,54,55,58,61,62,63],{"measure":10,"description":11,"timeFrame":12},"Overall response (OR)","OR as defined by RECIST 1.1 or any other validated clinical scale for response","month 3",{"measure":10,"description":11,"timeFrame":14},"month 6",{"measure":10,"description":11,"timeFrame":16},"month 9",{"measure":10,"description":11,"timeFrame":18},"month 12",{"measure":10,"description":11,"timeFrame":20},"month 15",{"measure":10,"description":11,"timeFrame":22},"month 18",{"measure":10,"description":11,"timeFrame":24},"month 21",{"measure":10,"description":11,"timeFrame":26},"month 24",{"measure":28,"description":29,"timeFrame":30},"Plasma proteomic profile","Plasma proteins measurments","Baseline, pre treatment",{"measure":28,"description":29,"timeFrame":32},"2(+\u002F-1) weeks from first treatment",{"measure":28,"description":29,"timeFrame":34},"3 months",{"measure":28,"description":29,"timeFrame":36},"6 months",{"measure":28,"description":29,"timeFrame":38},"9 months",{"measure":28,"description":29,"timeFrame":40},"12 months",{"measure":28,"description":29,"timeFrame":42},"15 months",{"measure":28,"description":29,"timeFrame":44},"18 months",{"measure":28,"description":29,"timeFrame":46},"21 months",{"measure":28,"description":29,"timeFrame":48},"24 months",{"measure":50,"description":51,"timeFrame":30},"Epigenetic patterns","Characterization of Cell free DNA",{"measure":50,"description":51,"timeFrame":32},{"measure":50,"description":51,"timeFrame":40},{"measure":50,"description":51,"timeFrame":48},{"measure":56,"description":56,"timeFrame":57},"ctDNA mutation analysis","immediately after surgery",{"measure":59,"description":60,"timeFrame":30},"Microbiome profiling","PBMC subpopulations exploration",{"measure":59,"description":60,"timeFrame":32},{"measure":59,"description":60,"timeFrame":40},{"measure":59,"description":60,"timeFrame":48},null,[66,70,74,77,78,79,80,82,83,84],{"measure":67,"description":68,"timeFrame":69},"Progression Free Survival (PFS)","Documentation of Progression Free Survival (PFS) duration","From date of enrollment until the date of first documented progression, assessed up to 100 months",{"measure":71,"description":72,"timeFrame":73},"Overall Survival (OS)","Documentaion of Overall Survival (OS) duration","From date of enrollment until the date of death from any cause, assessed up to 100 month",{"measure":75,"description":76,"timeFrame":34},"Adverse Events (AE)","AE, as reported by the patients",{"measure":75,"description":76,"timeFrame":36},{"measure":75,"description":76,"timeFrame":38},{"measure":75,"description":76,"timeFrame":40},{"measure":75,"description":76,"timeFrame":81},"15 monthst",{"measure":75,"description":76,"timeFrame":44},{"measure":75,"description":76,"timeFrame":46},{"measure":75,"description":76,"timeFrame":48},{"allocation":64,"interventionModel":64,"interventionModelDescription":64,"primaryPurpose":64,"observationalModel":86,"timePerspective":87,"maskingInfo":64},"OTHER","PROSPECTIVE","The goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of NSCLC patients, and their:\n\n* Response to treatment\n* Clinical benefit parameters such as PFS and OS.\n* Adverse events to immune check inhibitor therapy\n* Biological mechanisms involved in response or resistance to immune check inhibitor therapy.\n\nPatients will provide plasma, PBMCs, stool and tissue samples (where applicable) before and during treatment.\n\nClinical data, including disease history, given treatment, response evaluation and adverse events to the treatment will be recorded.\n\nSamples will be analysed as follows -\n\n* Proteomic features (Plasma proteomics)\n* Epigenetic patterns (cell free DNA)\n* ctDNA mutation analysis\n* PBMC subpopulations\n* Microbiome profiling (Stool)","Study population comprises 3 sub-populations:\n\nCohort 1 - Non-operable NSCLC (Stages IIIB to IV), receiving immune-check inhibitor (ICI) therapy \\[any combination of ICI \u002F ICI ±Chemotherapy, and any line of treatment\\].\n\nCohort 2 - Operable NSCLC (Stages II-IIIA), receiving ICI in the neoadjuvant or adjuvant setting.\n\nCohort 3 - Sex and aged matched non-diseased volunteers.",[91,96,100],{"label":92,"type":64,"description":93,"interventionNames":94},"Non-operable NSCLC patients receiving ICI therapy","Patients with non-operable stage IIIB-IV NSCLC treated with immune check inhibitor anti cancer treatment as a standard of care",[95],"Other: blood, stool and tissue samples collection",{"label":97,"type":64,"description":98,"interventionNames":99},"Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy","Patients with operable stage II-IIIA NSCLC, treated with immune check inhibitor in the neoadjuvant or adjuvant setting",[95],{"label":101,"type":64,"description":102,"interventionNames":103},"Healthy volunteers","Sex and aged matched non-diseased volunteers",[95],[105],{"type":86,"name":106,"description":107,"armGroupLabels":108,"otherNames":64},"blood, stool and tissue samples collection","blood, stool and tissue samples collection before and during the treatment, as applicable",[101,92,97],[110],{"name":111,"affiliation":112,"role":113},"Ronan J Kelly, MD MBA","Chief of Oncology Baylor Scott & White Health System","PRINCIPAL_INVESTIGATOR",[115,120],{"name":116,"role":117,"phone":118,"phoneExt":64,"email":119},"Galit Yahalom, PhD","CONTACT","97248537557","galit@oncohost.com",{"name":121,"role":117,"phone":118,"phoneExt":64,"email":122},"Shani Raveh Shoval, PhD","shani@oncohost.com",[124],{"facility":125,"status":126,"city":127,"state":128,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"Baylor Scott and White Research Institute","RECRUITING","Dallas","Texas","75204","United States","US",{"type":133,"coordinates":134},"Point",[135,136],-96.80667,32.78306,{"lat":136,"lon":135},[139,142],{"name":140,"role":117,"phone":64,"phoneExt":64,"email":141},"Pappu Himabindu","Himabindu.Pappu@BSWHealth.org",{"name":111,"role":113,"phone":64,"phoneExt":64,"email":64},{"type":144,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100495809",false,"NCT05736029","Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics","PROPHETIC Extended - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Extended Study.","PROPHETIC","Inclusion Criteria:\n\n* Provision of informed consent prior to any study-specific procedures.\n* Male or female aged at least 18 years.\n* ECOG PS - 0\u002F1-2.\n\nExclusion Criteria:\n\n* Any concurrent and\u002For other active malignancy that has required systemic treatment within 2 years of first dose of treatment.\n* Generalized impairment or mental incompetence that would render the patient unable to understand his\u002Fher participation in the study.",true,"ALL","18 Years",{"count":156,"type":157},350,"ESTIMATED","OBSERVATIONAL","The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients.\n\nThe investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm enabling to identify patients that could benefit from the immune check inhibitor based anti cancer treatment.\n\nPatients will provide biological samples before and during their treatment, and clinical data will be collected.",[161,162],"Non Small Cell Lung Cancer","Healthy","2023-02-09",{"date":165,"type":166},"2023-02-21","ACTUAL",{"date":168,"type":166},"2022-11-07",{"date":170,"type":157},"2028-06-30",{"name":5,"class":6},1]