RecruitingNCT04099290

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

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

50 participants

Start Date

Jan 14, 2020

Study Type

OBSERVATIONAL

Conditions

Carcinoma, Squamous Cell Head and Neck Neoplasm

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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

Exclusion Criteria5

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 skin cancers are eligible.
Patients with primary skin cancers of the head and neck, including basal or squamous cell cancers
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.

Interventions

OTHERBlood and tumor samples

Blood samples to be obtained at consent, post-operatively, post-adjuvant treatment, and at follow-up or recurrence. Tumor samples to be obtained at surgery and at time of recurrence or post-treatment biopsy, if applicable.