[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529488":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":75,"collaborators":10,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":10,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":10,"enrollmentInfo":86,"targetDuration":10,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Viome","INDUSTRY",[8,14,18],{"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 either primary or secondary care.",[13],"Device: Oral\u002FThroat cancer test",{"label":15,"type":10,"description":16,"interventionNames":17},"Oropharyngeal Squamous Cell Carcinoma (OPSCC)","OPSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from either primary or secondary care.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cancer-free","Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary and secondary care facilities.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DEVICE","Oral\u002FThroat cancer test","The Oral\u002FThroat cancer test is intended for the qualitative detection of molecular features (human genes, microbial species and functions) associated with Oral Squamous Cell Carcinoma (OSCC) or OroPharyngeal Squamous Cell Carcinoma (OPSCC) in saliva samples from adults with a suspicion of cancer. A positive result from CDOT may indicate the presence of OSCC or OPSCC. The device is intended as a diagnostic aid for clinicians when assessing patients with suspected OSCC or OPSCC who may benefit from follow-up diagnosis and treatment. The device is not intended for a definitive diagnosis.",[19,9,15],[29],{"name":30,"affiliation":5,"role":31},"Cristina Julian","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Mory Mehrtash","CONTACT","425-300-6933","studies@viome.com",{"name":39,"role":35,"phone":36,"phoneExt":10,"email":37},"Momchilo Vuyisich",[41,60],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Missouri School of Dentistry & Oral Health","RECRUITING","St Louis","Missouri","63104","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-90.19789,38.62727,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":58,"phoneExt":10,"email":59},"Adepitan Owosho","314-833-2729","adepitanowosho@atsu.edu",{"facility":61,"status":43,"city":62,"state":63,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"UTHSC","Memphis","Tennessee","38163",{"type":50,"coordinates":66},[67,68],-90.04898,35.14953,{"lat":68,"lon":67},[71],{"name":72,"role":35,"phone":73,"phoneExt":10,"email":74},"Yanhui Zhang, Ph.D.","901.448.3751","yzhang36@uthsc.edu",{"type":76,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100529488","validity-of-viomes-oralthroat-cancer-test-100529488",false,"NCT06174428","Validity of Viome's Oral\u002Fthroat Cancer Test","Validity of Viome's Oral\u002Fthroat Cancer Test Among Patients with a Suspicion of Cancer","Inclusion Criteria:\n\n* Signed and dated informed consent prior to any study-specific procedures are performed\n* Willing and able to follow the study instructions, as described in the recruitment letter\n* Adults (18 years old or older)\n* Suspicion of OSCC or OPSCC on clinical presentation by a clinician\n\nExclusion Criteria:\n\n* Pregnancy\n* Use of fertility enhancing medications","ALL","18 Years",{"count":87,"type":88},1000,"ESTIMATED","OBSERVATIONAL","A total of at least 1,000 participants with suspicion of cancer including at least 107 subjects who will be diagnosed with OSCC or OPSCC will be enrolled from either primary or secondary care centers in the U.S. Clinicians will use Viome collection kits to collect saliva samples from eligible patients.",[92,93,94],"Oral and Throat Cancer","Oropharyngeal Squamous Cell Carcinoma","Oral Squamous Cell Carcinoma",[96,97,98,99,100],"OSCC","OPSCC","Oral Cancer","Throat cancer","Oral and Throat cancer","2025-01-27",{"date":103,"type":104},"2025-01-29","ACTUAL",{"date":101,"type":104},{"date":107,"type":88},"2026-12",{"name":5,"class":6},2]