[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473931":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":10,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":10,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Viome","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Squamous Cell Carcinoma (OSCC)",null,"OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.",[13],"Device: OralViome Cancer Testing System",{"label":15,"type":10,"description":16,"interventionNames":17},"OroPharyngeal Cancer (OPC)","OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Oral Potentially Malignant Disease (OPMD)","OPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to:\n\n* Dysplasia\n* Hyperplasia\n* Leukoplakia\n* Erythroplasia\n* Lichenoid lesions\n* Actinic Keratosis\n* Lichenoid reaction\n* Aphthous ulcer\u002F Canker Sores\n* Gingival enlargement (side effect)\n* Lichen planus\n* Keratosis\n* Inflammatory reaction\n* Cheek bites",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cancer-free","Cancer free control cohort will be matched with cases. Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary care facilities.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DEVICE","OralViome Cancer Testing System","The OralViome Cancer Testing System is intended for the screening of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal cancer (OPC). The system consists of the OralViome Saliva Collection and Transport Kit, the Viome laboratory process for metatranscriptomics, and the Viome analytical software that detects an RNA expression signature within a saliva sample.",[23,19,9,15],[33],{"name":34,"affiliation":5,"role":35},"Cristina Julian, PhD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Mory Mehrtash, MSc","CONTACT","425-300-6933","studies@viome.com",{"name":43,"role":39,"phone":40,"phoneExt":10,"email":41},"Momchilo Vuyisich, PhD",[45],{"facility":46,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"NYMC","RECRUITING","New York","10595","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-74.00597,40.71427,{"lat":56,"lon":55},[59],{"name":60,"role":39,"phone":61,"phoneExt":10,"email":10},"Mohanapriya Rajamoorthy","(914) 594-4575",{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[65],{"name":66,"class":67},"New York Medical College","OTHER","100473931","detection-of-oral-and-throat-cancers-using-oralviome-cancer-testing-system-100473931",false,"NCT05451303","Detection of Oral and Throat Cancers Using OralViome Cancer Testing System","Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis","Inclusion Criteria\n\n* Signed Informed Consent obtained\n* 18 years and older\n* At a high risk of developing oral or throat cancer based on clinician's discretion\n\nExclusion Criteria\n\n* Pregnancy\n* Use of fertility enhancing medications",true,"ALL","18 Years",{"count":79,"type":80},475,"ESTIMATED","OBSERVATIONAL","To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.",[84,85,86],"Oral Squamous Cell Carcinoma","Oropharynx Squamous Cell Carcinoma","Premalignant Lesion",[5,88,89,90,91,92,93,94,95,96],"oral cancer","detection","OSCC","OPMD-B","OPMD-PM","OPMD","OPV","Tobacco","HPV","2025-01-27",{"date":99,"type":100},"2025-01-29","ACTUAL",{"date":102,"type":100},"2022-05-27",{"date":104,"type":80},"2026-12",{"name":5,"class":6},1]