Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

• •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/or surgical resection (archival tissue) and serial blood draws will be required for enrollment.
• •Age ≥ 18 years of age on day of signing informed consent
• •Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck, including the following subtypes: oral cavity, oropharynx, larynx
• •Must be planning to undergo gross total resection of the primary tumor with curative intent at UNC-CH hospital
• •No prior, definitive therapy to primary tumor. Must meet one of the following clinical stages: T3-T4 (if T1/T2 must have nodal involvement), Any N, M0
• •Patient must be amenable to receiving adjuvant therapy with radiotherapy +/- systemic therapy, as clinically indicated, based on either standard of care (SOC) or appropriate clinical trial.
• •Diagnostic tumor material must be available for correlative analysis
• •Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee