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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Squamous Cell; Head and Neck Neoplasm
• Intervention / Treatment: Other: Blood and tumor samples

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Siddharth Sheth, MD; Phone Number: (919) 966-3856; Email: Siddharth.Sheth@unchealth.unc.edu
• Study Contact Backup: Name: Rebecca Green, MSW; Phone Number: (984) 974-8440; Email: rlgreen@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Siddharth Sheth, MD; Email: siddharth.sheth@unchealth.unc.edu
      • Contact: Rebecca Green, MSW; Phone Number: 984-974-8440; Email: rlgreen@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Head and Neck Cancer

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: American Society of Clinical Oncology
• Investigators: Principal Investigator: Siddharth Sheth, MD, UNC Health Care; Principal Investigator: Gaorav Gupta, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2020
• Primary Completion (Estimated): February 2, 2026
• Study Completion (Estimated): February 2, 2026

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Squamous Cell Carcinoma; Circulating Tumor DNA
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: LCCC 1835

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No