Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Blood and tumor samples
Treatment groups
No treatment groups listed
Sponsors and collaborators
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
American Society of Clinical Oncology
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov