Recruiting

ctDNA

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT04099290

Conditions

Head and Neck Neoplasm

Carcinoma, Squamous Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood and tumor samples

Study Details

Brief 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.

Conditions

Head and Neck Neoplasm

Carcinoma, Squamous Cell

Study ID

NCT04099290

Start date

Jan 14, 2020

Status verified date

Feb, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Blood and tumor samples

Blood samples to be obtained at consent, post-operatively, post-adjuvant treatment, and at follow-up or recurrence. Tumor samples to be obtained at surgery and at time of recurrence or post-treatment biopsy, if applicable.

Primary outcome measure

  • 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 [ Time Frame: Time of consent ]

Central Contacts and Locations

Central contacts

Siddharth Sheth, MD

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

Rebecca Green, MSW

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

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Siddharth Sheth, MD

siddharth.sheth@unchealth.unc.edu

Rebecca Green, MSW

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

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • Squamous Cell Carcinoma
  • Circulating Tumor DNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-02-06.