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
N/A
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
Researchers are studying patients with locally advanced squamous cell carcinoma of the head and neck who are planning to have surgery to remove their cancer. The study aims to measure levels of circulating tumor DNA (ctDNA), which indicates cancer cells in the blood, before and after surgery. They want to understand how ctDNA changes over time and if certain tumor or patient features are linked to higher ctDNA levels, as well as explore if ctDNA detection after surgery is related to cancer coming back. The study collects tumor tissue during surgery to identify specific genetic mutations using advanced DNA testing technology called PCR. Blood samples are taken before surgery and at various times after surgery, including after additional treatments and during follow-up visits, to detect and measure ctDNA. Tumor samples may also be collected again if cancer recurs or after treatment. These specimens are gathered during planned clinical assessments. Participants will provide blood samples and tumor tissue at scheduled times: at consent, post-surgery, after adjuvant treatment, and during follow-up visits for up to several years if needed. The research team will analyze tumor mutations, changes in ctDNA levels, and their relation to surgical outcomes such as margins and cancer spread. This monitoring helps evaluate ctDNA as a marker for tumor presence and recurrence. The study involves ongoing clinical assessments and laboratory analyses over time.
CONDITIONS
Brief 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 for study participation and use of biopsy or surgical tissue and blood samples
- Age 18 years or older at the time of consent
- Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck including oral cavity, oropharynx, or larynx subtypes
- Planning to undergo gross total surgical removal of the primary tumor with curative intent at UNC-CH hospital
- No prior definitive therapy to the primary tumor; must have 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 the investigator or designee
You will not qualify if you...
- Evidence of metastatic disease based on clinical or radiographic studies
- Women who are pregnant or nursing
- History of another primary cancer in the last 5 years, except in situ cancers or localized basal or squamous cell skin cancers
- Primary skin cancers of the head and neck, including basal or squamous cell cancers
- Prior chemotherapy, intraperitoneal, biologic, or hormonal therapy specifically for head and neck squamous cell carcinoma treatment; concurrent hormonal therapy for non-cancer conditions is allowed
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgery to remove the primary tumor and tumor samples are collected for mutation analysis.
1 visit (in-person)
Duration - Approximately 1 to 4 weeks after surgery
Participants provide blood samples post-operatively to measure circulating tumor DNA and are monitored during recovery.
1 visit (in-person)
Duration - Approximately 6 weeks following initiation of treatment
Participants provide blood samples approximately 6 weeks after starting adjuvant treatment to assess ctDNA levels.
1 visit (in-person)
Duration - Up to 2 years or up to 5 years if recurrence occurs
Participants provide blood samples every 3 months up to 2 years and at disease recurrence if applicable to monitor ctDNA over time.
Blood samples collected every 3 months during follow-up visits
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
R
Rebecca Green, MSW
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
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