Actively Recruiting
Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-02-06
50
Participants Needed
1
Research Sites
367 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
A
American Society of Clinical Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization obtained
- Age 18 years or older at time of consent
- Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx)
- Planning gross total resection surgery of the primary tumor with curative intent at UNC-CH hospital
- No prior definitive therapy to the primary tumor
- Clinical stage T3-T4, or T1-T2 with nodal involvement; any N, M0
- Amenable to receiving adjuvant radiotherapy with or without systemic therapy, as clinically indicated
- Diagnostic tumor material available for correlative analysis
- Willing and able to comply with study procedures as judged by investigator or designee
You will not qualify if you...
- Known metastatic disease by clinical or radiographic studies
- Pregnant or nursing women
- History of another primary malignancy within last 5 years, except in situ cancer or basal/localized squamous cell skin cancers
- Primary skin cancers of head and neck (including basal or squamous cell cancers)
- Prior chemotherapy, immunotherapy, biologic, or hormonal therapy for HNSCC treatment
- Concurrent hormonal therapy for non-cancer conditions is allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
S
Siddharth Sheth, MD
CONTACT
R
Rebecca Green, MSW
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here