NCT04099290Recruiting
Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 17 Sept 2019
- Start date
- 14 Jan 2020
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT04099290
What you commit to
- Study type: Observational
- Planned participants: 50
- From 14 Jan 2020 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Has known evidence of metastatic disease based on clinical or radiographic studies
- Patients with primary skin cancers of the head and neck, including basal or squamous cell cancers
Other
- Women who are pregnant or nursing
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.