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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with Head and Neck Cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood and tumor samples
Other interventionBlood 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rate of tumor-specific mutation in pre-operative circulating tumor DNA of patients with locally-advanced HNSCC who are receiving surgery for treatment of their primary tumor
Time frame
Time of consentSecondary outcomes
1
Rate of tumor-specific mutation in post-operative circulating tumor DNA in patients with locally-advanced HNSCC who received surgery for treatment of their primary tumor
Time frame
Post-surgery/pre-treatment, post-surgery/post-treatment (approximately 6 weeks following initiation of treatment and every 3 months up to 2 years), and at disease recurrence if applicable (up to 5 years)2
Change in ctDNA levels (i.e., copies per mL plasma) over time
Time frame
Time of consent, post-operatively (approximately 1-4 weeks after surgery), post-adjuvant treatment (approximately 6 weeks following initiation of treatment) and follow-up (every 3 months up to 2 years)/recurrence if applicable (up to 5 years)3
Description of tumor-specific mutations in surgical specimens by NGS
Time frame
Surgery and post-treatment biopsy/recurrence if applicable(up to 5 years)4
Correlation between post-operative plasma ctDNA levels and surgical margins
Time frame
Post-operatively (approximately 1-4 weeks after surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
American Society of Clinical Oncology
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov