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Observational Study of Circulating Tumor DNA in Head and Neck Cancer

This observational study is looking at circulating tumor DNA (ctDNA) in people with locally advanced head and neck squamous cell carcinoma (a type of cancer). ctDNA is genetic material from cancer cells that can be found in the blood. Researchers want to see how ctDNA levels change after surgery and over time. They also want to understand if certain features of your tumor or you as a patient affect ctDNA levels, and if finding ctDNA after surgery is linked to the cancer coming back. To do this, they will collect blood and tumor samples at different times, including before and after surgery. The study aims to enroll 50 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any new treatments. It plans to enroll 50 participants.
What's involved
You would provide blood samples at several points: at the start, after surgery, after any additional treatments, and during follow-up or if the cancer returns. Tumor samples would be taken during surgery and if the cancer returns or a biopsy is done after treatment.
Compensation
Not stated in the trial record.
Follow-up
Blood and tumor samples will be collected at follow-up or recurrence, suggesting ongoing monitoring after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04099290

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

Recruiting
Not specifiedAges 18+Observational
UNC Lineberger Comprehensive Cancer Center
~50 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Blood and tumor samples

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Time of consent

Conditions

Head and Neck Neoplasm
Carcinoma, Squamous Cell

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Siddharth Sheth, MD · PRINCIPAL_INVESTIGATOR · UNC Health Care
  • Gaorav Gupta, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Siddharth Sheth, MD
[email protected]
(919) 966-3856
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
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.

What this trial measures

  • 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 tumorTime of consent