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

NCT04099290 | Recruiting DMC

• 2 other identifiers: LCCC 18355K12CA120780-15
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Squamous Cell Carcinoma; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

• 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 of consent

Secondary Outcomes (5)

• Rate of tumor-specific mutation in post-operative circulating tumor DNA in patients with locally-advanced HNSCC who received surgery for treatment of their primary tumor

  Post-surgery/pre-treatment, post-surgery/post-treatment (approximately 6 weeks following initiation of treatment and every 3 months up to 2 years), and at disease recurrence if applicable (up to 5 years)

• Change in ctDNA levels (i.e., copies per mL plasma) over time

  Time of consent, post-operatively (approximately 1-4 weeks after surgery), post-adjuvant treatment (approximately 6 weeks following initiation of treatment) and follow-up (every 3 months up to 2 years)/recurrence if applicable (up to 5 years)

• Description of tumor-specific mutations in surgical specimens by NGS

  Surgery and post-treatment biopsy/recurrence if applicable(up to 5 years)

• Correlation between post-operative plasma ctDNA levels and surgical margins

  Post-operatively (approximately 1-4 weeks after surgery)

• Correlation between post-operative plasma ctDNA levels and extra-capsular extension

  Post-operatively (approximately 1-4 weeks after surgery)

Interventions

Blood and tumor samples OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Head and Neck Cancer

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• American Society of Clinical Oncology: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Siddharth Sheth, MD

  UNC Health Care

  PRINCIPAL INVESTIGATOR

• Gaorav Gupta, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siddharth Sheth, MD

CONTACT

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

Rebecca Green, MSW

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 23, 2019
• Study Start: January 14, 2020
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)