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Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma | Clinical Trials | Clareo Health

RECRUITING

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

NCT04099290•UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The investigators will take a piece of the tumor from the surgery and determine if they can identify mutations, or changes in the genetic makeup of the cells due to cancer, that are specific to the tumor. Based on this information, the investigators will design a test using PCR, which is a technology that allows for the amplification of the DNA, that is specific to the mutation identified in the tumor. Once verified, the presence (or absence) of ctDNA in the blood can be measured. The investigators will measure this blood test prior to surgery and at multiple time points following surgery. Specimens will be collected at the time of planned clinical assessments.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Key Dates

Start Date

January 14, 2020

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

February 6, 2026

Enrollment

ESTIMATED participants

Conditions

Head and Neck NeoplasmCarcinoma, Squamous Cell

Interventions

Blood and tumor samples

OTHER

Contacts

Siddharth Sheth, MD

CONTACT

(919) 966-3856 Siddharth.Sheth@unchealth.unc.edu

Rebecca Green, MSW

CONTACT

(984) 974-8440 rlgreen@med.unc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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