[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539579":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":31,"locations":37,"responsibleParty":79,"collaborators":81,"id":85,"slug":10,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":10,"enrollmentInfo":94,"targetDuration":10,"studyType":97,"phases":10,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Case Group",null,"Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases.",[13],"Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel",{"label":15,"type":10,"description":16,"interventionNames":17},"Control Group","Controls will be enrolled from members of the catchment area to ensure geographic comparability of cases and controls. Controls will be matched by sex, age, race\u002Fethnicity, and tobacco use.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","combined HPV 16 DNA and host gene methylation oral biomarker panel","DNA Methylation Profiling",[9,15],[25,29],{"name":26,"affiliation":27,"role":28},"Anna Giuliano, PhD","Moffitt Cancer Center","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":27,"role":28},"Antonio Amelio, PhD",[32],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Kimberly Isaacs-Soriano","CONTACT","813-745-6992","kimberly.Isaacs-Soriano@moffitt.org",[38,62],{"facility":27,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Tampa","Florida","33612","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-82.45843,27.94752,{"lat":49,"lon":48},[52,53,54,55,58,60],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},{"name":26,"role":28,"phone":10,"phoneExt":10,"email":10},{"name":30,"role":28,"phone":10,"phoneExt":10,"email":10},{"name":56,"role":57,"phone":10,"phoneExt":10,"email":10},"Jimmy Caudell, MD, PhD","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":10,"phoneExt":10,"email":10},"Christine Chung, MD",{"name":61,"role":57,"phone":10,"phoneExt":10,"email":10},"Bruce Wenig, MD",{"facility":63,"status":39,"city":64,"state":65,"zip":66,"country":43,"countryCode":44,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center","Pittsburgh","Pennsylvania","15232",{"type":46,"coordinates":68},[69,70],-79.99589,40.44062,{"lat":70,"lon":69},[73,76],{"name":74,"role":34,"phone":10,"phoneExt":10,"email":75},"Jose P. Zevallos, MD, PhD","zevallosjp@upmc.edu",{"name":77,"role":34,"phone":10,"phoneExt":10,"email":78},"Robert Ferris, PhD","ferrrl@UPMC.EDU",{"type":80,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[82],{"name":83,"class":84},"National Institutes of Health (NIH)","NIH","100539579",false,"NCT06305676","Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)","BASH OPC","Inclusion Criteria:\n\nCases:\n\n* Aged at least 18 years\n* Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)\n* Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks\n* Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker\u002Fbiobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center\n* Aged at least 35 years\n* Have no previous diagnosis of HNC or HPV-related cancer\n* Fully understands study procedures\n* Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker\u002Fbiobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center\n\nExclusion Criteria:\n\n* Not meeting all of the above inclusion criteria for either the case or control group",true,"ALL","18 Years",{"count":95,"type":96},400,"ESTIMATED","OBSERVATIONAL","Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race\u002Fethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).",[100,101],"Oropharyngeal Cancer","HPV-Related Carcinoma",[100,103,104],"Early Detection","Screening","2026-02-05",{"date":107,"type":108},"2026-02-09","ACTUAL",{"date":110,"type":108},"2024-01-22",{"date":112,"type":96},"2029-01",{"name":5,"class":6},2]