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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Siddharth Sheth, MD
Siddharth.Sheth@unchealth.unc.edu
(919) 966-3856
Backup
Rebecca Green, MSW
rlgreen@med.unc.edu
(984) 974-8440
Time Frame
Start Date: 2020-01-14
Estimated Completion Date: 2026-02-02
Participants
Target number of participants: 50
Sponsors
Collaborators: American Society of Clinical Oncology, National Cancer Institute (NCI)
Leads: UNC Lineberger Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov