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

NCT ID: NCT04099290

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2026-02-02

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.

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.

Conditions

Head and Neck Neoplasm; Carcinoma, Squamous Cell

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Clinical Oncology

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siddharth Sheth, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Health Care

Gaorav Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Siddharth Sheth, MD

Role: CONTACT

Siddharth.Sheth@unchealth.unc.edu

(919) 966-3856

Rebecca Green, MSW

Role: CONTACT

rlgreen@med.unc.edu

(984) 974-8440

Facility Contacts

Siddharth Sheth, MD

Role: primary

siddharth.sheth@unchealth.unc.edu

Rebecca Green, MSW

Role: backup

rlgreen@med.unc.edu

984-974-8440

Other Identifiers

5K12CA120780-15

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC 1835

Identifier Type: -

Identifier Source: org_study_id