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

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Sep 19, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a blood test called circulating tumor DNA (ctDNA) to learn more about head and neck squamous cell carcinoma, a type of cancer that affects the mouth, throat, and larynx. The researchers want to see how the levels of ctDNA change before and after surgery to remove the cancer and whether certain characteristics of the tumor or patient may lead to higher ctDNA levels. They are also interested in finding out if the presence of ctDNA after surgery could indicate a higher chance of the cancer coming back.

To participate in this trial, individuals must be at least 18 years old and have a newly diagnosed case of squamous cell carcinoma in the head or neck that has not been treated before. They should be planning to undergo surgery to remove the cancer at UNC-CH hospital and may need to receive additional treatments afterward, like radiation. Participants will be asked to provide blood samples and may have some of their tumor tissue analyzed. The goal is to gather important information that could help improve treatment for future patients.

Gender

ALL

Eligibility criteria

• 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
• 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 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.