[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-neoplasm":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100543469","oropharynx-opx-biomarker-trial-100543469",false,"NCT06356272","Oropharynx (OPX) Biomarker Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to provide written consent\n* Groups 1-3:\n\n  * Must undergo p16 staining on biopsy for enrollment\n  * Patients with \\\u003C 70% of tumor cells positive for p16 will be considered p16 negative\n  * Must undergo HPV16 family in situ hybridization (ISH) and\u002For RNA on biopsy or surgical specimen, unless amount of tissue is too small to have conclusive HPV ISH testing done on it\n  * Willingness and intent to return in person to enrolling institution for follow-up (during the Active Monitoring Phase of the study) for at least 2 of the standard follow-up time points for a total of 3 time-points including pre-treatment. A participant who does not return in person to Mayo Clinic Rochester for every standard of care post-treatment follow up will not be considered deviating from the protocol\n* Group 4:\n\n  * Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm\n\n    * Primary salivary neoplasm\n    * Primary thyroid neoplasm\n    * Primary head and neck neoplasm\n    * Multi-cancer early detection (MCED) testing concerning for cancer\n* Patient has given permission to give his\u002Fher tumor\u002Ftissue\u002Fblood\u002Fsaliva sample for research testing\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Primary language: English, Spanish, Arabic\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.\n* Groups 1-3:\n\n  * Other active malignancy ≤ 5 years prior to registration\n\n    * EXCEPTIONS: Non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, HPV+ oropharyngeal squamous cell carcinoma (SCC) (which can be enrolled in group 3)\n    * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer\n  * History of any head and neck malignancy, other than the tumor for which they are being treated\n* Group 4, Cohort A, B, C:\n\n  * Other active malignancy ≤ 5 years prior to registration\n\n    * EXCEPTIONS: Non-metastatic prostate cancer, carcinoma-in-situ of the cervix, non metastatic cutaneous basal cell carcinoma\n    * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer\n  * History of any head and neck malignancy, other than the present neoplasm\n  * Note these are clarifications of inclusion into Group 4, Cohorts D and E:\n\n    * Presence of other active malignancy or recurrent head and neck neoplasms are allowed in this arm\n    * Receipt of cancer specific therapy for other malignancy is allowed in this arm","ALL","18 Years",{"count":18,"type":19},560,"ESTIMATED","OBSERVATIONAL","The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent.",[23,24,25,26,27,28,29,30,31,32,33],"Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Metastatic Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Head and Neck Carcinoma","Head and Neck Neoplasm","Salivary Gland Neoplasms","Thyroid Gland Neoplasm","RECRUITING","2026-04-17",{"date":37,"type":38},"2026-04-22","ACTUAL",{"date":40,"type":38},"2019-11-15",{"date":42,"type":19},"2029-11-30",{"name":44,"class":45},"Mayo Clinic","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":46},"100370126","circulating-tumor-dna-ctdna-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-100370126","NCT04099290","Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and\u002For surgical resection (archival tissue) and serial blood draws will be required for enrollment.\n* Age ≥ 18 years of age on day of signing informed consent\n* Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck, including the following subtypes: oral cavity, oropharynx, larynx\n* Must be planning to undergo gross total resection of the primary tumor with curative intent at UNC-CH hospital\n* No prior, definitive therapy to primary tumor. Must meet one of the following clinical stages: T3-T4 (if T1\u002FT2 must have nodal involvement), Any N, M0\n* Patient must be amenable to receiving adjuvant therapy with radiotherapy +\u002F- systemic therapy, as clinically indicated, based on either standard of care (SOC) or appropriate clinical trial.\n* Diagnostic tumor material must be available for correlative analysis\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee\n\nExclusion Criteria:\n\n* Has known evidence of metastatic disease based on clinical or radiographic studies\n* Women who are pregnant or nursing\n* History of another primary malignancy in the last 5 years prior to registration. Patients with history of in situ cancer or basal or localized squamous cell skin cancers are eligible.\n* Patients with primary skin cancers of the head and neck, including basal or squamous cell cancers\n* Prior chemotherapy, IP, biologic, or hormonal therapy for HNSCC treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.",{"count":54,"type":19},50,"Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are planning to receive surgery to remove their head and neck cancer. The investigators are interested to learn how ctDNA levels change with surgery and over the course of time. The investigators also want to determine if there are certain features of the tumor or the patient themselves that might cause ctDNA to be higher than other patients. Also, the investigators want to explore if the detection of ctDNA following surgery is related to cancer recurrence.",[31,57],"Carcinoma, Squamous Cell",[59,60],"Squamous Cell Carcinoma","Circulating Tumor DNA","2026-02-05",{"date":63,"type":38},"2026-02-06",{"date":65,"type":38},"2020-01-14",{"date":67,"type":19},"2027-02-01",{"name":69,"class":45},"UNC Lineberger Comprehensive Cancer Center"]