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 HIPAAauthorization for release of personal health information. Consent for the use of anyresidual material from biopsy and/or surgical resection (archival tissue) and serialblood 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 andneck, including the following subtypes: oral cavity, oropharynx, larynx

• Must be planning to undergo gross total resection of the primary tumor with curativeintent at UNC-CH hospital

• No prior, definitive therapy to primary tumor. Must meet one of the followingclinical 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) orappropriate clinical trial.

• Diagnostic tumor material must be available for correlative analysis

• Subject is willing and able to comply with study procedures based on the judgementof the investigator or protocol designee

Exclusion Criteria:

• Has known evidence of metastatic disease based on clinical or radiographic studies

• Women who are pregnant or nursing

• 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 skincancers are eligible.

• Patients with primary skin cancers of the head and neck, including basal or squamouscell cancers

• Prior chemotherapy, IP, biologic, or hormonal therapy for HNSCC treatment.Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormonereplacement therapy) is acceptable.